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nli4ct_semeval2024

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[ "Outcome Measurement: ", " Proportion of Participants With a Pathologic Complete Response Rate", " To estimate the pathologic complete response rate (pCR) when pertuzumab is added to weekly trastuzumab/paclitaxel followed by trastuzumab/5-fluorouracil, epirubicin and cyclophosphamide neoadjuvant chemotherapy in HER2-positive breast cancer. This study will assess pCR rates separately in ER+ and ER- cancers. Pathologic complete response is defined as no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen. Residual Disease (RD) is defined as: Any invasive cancer in the breast or axillary lymph nodes in the surgical specimen.", " Time frame: 20 weeks", "Results 1: ", " Arm/Group Title: Chemo Plus Pertuzumab,Trastuzumab", " Arm/Group Description: During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).", " Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)", " Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).", " For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).", " Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).", " 5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).", " Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).", " Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).", " Overall Number of Participants Analyzed: 48", " Measure Type: Number", " Unit of Measure: proportion of participants HR Positive: 23 participants", " .26 (.13 to .46)", " HR Negative: 25 participants", " .80 (.60 to .91)" ]

[ "Outcome Measurement: ", " Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population", " CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.", " Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)", "Results 1: ", " Arm/Group Title: Dasatinib Plus Letrozole", " Arm/Group Description: Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years", " Dasatinib 100 mg + Letrozole 2.5 mg", " Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days", " Overall Number of Participants Analyzed: 56", " Measure Type: Number", " Unit of Measure: participants CBR (CR+PR+SD): 40", " CBR, DFI <= 2 Years: 20", "CBR, DFI > 2 Years: 20", "Results 2: ", " Arm/Group Title: Letrozole", " Arm/Group Description: Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years", " Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days", " Overall Number of Participants Analyzed: 61", " Measure Type: Number", " Unit of Measure: participants CBR (CR+PR+SD): 40", " CBR, DFI <= 2 Years: 20", "CBR, DFI > 2 Years: 20" ]

[ "Outcome Measurement: ", " Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)", " OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.", " Time frame: From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)", "Results 1: ", " Arm/Group Title: Lapatinib 1500 mg QD", " Arm/Group Description: Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.", " Overall Number of Participants Analyzed: 69", " Measure Type: Number", " Unit of Measure: Participants CR: 0", "PR: 15", "Results 2: ", " Arm/Group Title: Lapatinib 500 mg BID", " Arm/Group Description: Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.", " Overall Number of Participants Analyzed: 69", " Measure Type: Number", " Unit of Measure: Participants CR: 0", "PR: 18" ]

[ "Outcome Measurement: ", " Pathological Complete Response Rates at Surgery", " [Not Specified]", " Time frame: at surgery approximately 5 months after initial treatment", "Results 1: ", " Arm/Group Title: Cohort 1", " Arm/Group Description: Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks", " Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)", " Overall Number of Participants Analyzed: 28", " Measure Type: Number", " Unit of Measure: participants 16", "Results 2: ", " Arm/Group Title: Cohort 2", " Arm/Group Description: Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks", " Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)", " Overall Number of Participants Analyzed: 27", " Measure Type: Number", " Unit of Measure: participants 2" ]

[ "Outcome Measurement: ", " Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC;", " These numbers represent patients with a RCB score of zero (0). RCB stands for residual cancer burden.", "Time frame: 1 year", "Results 1: ", " Arm/Group Title: Cohort 1", " Arm/Group Description: [Not Specified]", " Overall Number of Participants Analyzed: 37", " Measure Type: Number", " Unit of Measure: participants 12", "Results 2: ", " Arm/Group Title: Cohort 2", " Arm/Group Description: [Not Specified]", " Overall Number of Participants Analyzed: 23", " Measure Type: Number", " Unit of Measure: participants 13" ]

[ "Adverse Events 1:", " Total: 29/48 (60.42%)", " Anemia 4/48 (8.33%)", " Febrile neutropenia 7/48 (14.58%)", " Atrial fibrillation 1/48 (2.08%)", " Pericardial effusion 1/48 (2.08%)", " Sinus bradycardia 1/48 (2.08%)", " Nausea 2/48 (4.17%)", " Vomiting 2/48 (4.17%)", " Death NOS 1/48 (2.08%)", " Fatigue 3/48 (6.25%)", " Allergic reaction 1/48 (2.08%)", " Lung infection 1/48 (2.08%)", " Mucosal infection 1/48 (2.08%)" ]

[ "Adverse Events 1:", " Total: 28/39 (71.79%)", " Anemia 1/39 (2.56%)", " Leukopenia 4/39 (10.26%)", " Neutropenia 4/39 (10.26%)", " Chest Pain 1/39 (2.56%)", " Pericarditis 1/39 (2.56%)", " Sinus Tach. 1/39 (2.56%)", " Sinus Tachycardia 1/39 (2.56%)", " Eye tearing 1/39 (2.56%)", " Diarrhea 7/39 (17.95%)", " Mucositis 3/39 (7.69%)", " Nausea 2/39 (5.13%)", " Vomiting [1]1/39 (2.56%)", " Fatigue 6/39 (15.38%)" ]

[ "INTERVENTION 1: ", " LBH589 With Capecitabine", " MTD, LBH589 with Capecitabine", " LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.", " Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.", "INTERVENTION 2: ", " LBH589 and Lapatinib", " LBH589 and Lapatinib", " LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.", " Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination." ]

[ "Outcome Measurement: ", " CNS Objective Response Rate (ORR)", " The central nervous system (CNS) ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria in the evaluation CNS lesions on treatment: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.", " Time frame: Disease assessments occurred every 6 cycles. Patients with stable or responsive disease after completion of 6 cycles could reduce frequency of assessments to every 3 cycles. Response was evaluated up to 25 months.", "Results 1: ", " Arm/Group Title: Cohort 1 - Cabozantinib, Trastuzumab for HER2+", " Arm/Group Description: HER2-positive", " Cabozantinib- orally administered daily per treatment cycle", " Trastuzumab- IV administered once per cycle", " MRI- Baseline, Cycle 2 Day 1, and every 2 cycles", " Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,", " Cabozantinib: One, 60 mg tablet daily of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.", " Trastuzumab: For HER2-Positive participants only. Administered by IV on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.", " Overall Number of Participants Analyzed: 21", " Measure Type: Number", " Unit of Measure: percentage of participants 5 (.2 to 24)", "Results 2: ", " Arm/Group Title: Cohort 2 - Cabozantinib for ER+ and/or PR+", " Arm/Group Description: Hormone receptor-positive (ER+ and/or PR+)", " Cabozantinib- orally administered daily per treatment cycle", " MRI- Baseline, Cycle 2 Day 1, and every 2 cycles", " Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,", " Cabozantinib: One, 60 mg tablet daily of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.", " Overall Number of Participants Analyzed: 7", " Measure Type: Number", " Unit of Measure: percentage of participants 14 (.4 to 58)" ]

[ "Outcome Measurement: ", " Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Intracranial Response Rate (OIRR)", " OIRR is the percentage of participants with a (CR) or (PR) based on the Response Assessment in Neuro-Oncology Brain Metastasis (RANO-BM) response criteria. CR is measurable target lesions, the disappearance of all central nervous system (CNS) target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum longest duration (LD) of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Nontarget lesions requires disappearance CNS non-target lesions and no new CNS lesions. Stable disease (SD) is less than (<)30% decrease relative to baseline but <20% increase in sum LD relative to nadir. Progressive disease (PD) is greater than or equal to ( ) 20% increase in sum LD relative to nadir and a relative increase of 20%, 1 lesion must increase by absolute value of 5 millimeter (mm).", " Time frame: Baseline to Objective Disease Progression (Up to 36 Months)", "Results 1: ", " Arm/Group Title: Part A Abemaciclib: HR+, HER2+ Breast Cancer", " Arm/Group Description: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.", " Overall Number of Participants Analyzed: 23", " Measure Type: Number", " Unit of Measure: percentage of participants 0", "Results 2: ", " Arm/Group Title: Part B Abemaciclib: HR+, HER2- Breast Cancer", " Arm/Group Description: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET).", " Participants may continue to receive treatment until discontinuation criteria are met.", " Overall Number of Participants Analyzed: 52", " Measure Type: Number", " Unit of Measure: percentage of participants 5.8" ]

[ "Adverse Events 1:", " Total: 7/39 (17.95%)", " Gastroenteritis viral 1/39 (2.56%)", " Parainfluenzae virus infection 1/39 (2.56%)", " Seizure 4/39 (10.26%)", " Headache 1/39 (2.56%)", " Hydrocephalus 1/39 (2.56%)", " Hypertension 1/39 (2.56%)" ]

[ "Adverse Events 1:", " Total: 20/70 (28.57%)", " NAUSEA 2/70 (2.86%)", " VOMITING 1/70 (1.43%)", " DIARRHOEA 2/70 (2.86%)", " ABDOMINAL PAIN 1/70 (1.43%)", " ABDOMINAL PAIN LOWER 1/70 (1.43%)", " FATIGUE 2/70 (2.86%)", " PYREXIA 1/70 (1.43%)", " OEDEMA PERIPHERAL 1/70 (1.43%)", " GENERAL PHYSICAL HEALTH DETERIORATION 3/70 (4.29%)", " PNEUMONIA 1/70 (1.43%)", " SINUSITIS 1/70 (1.43%)", " LOBAR PNEUMONIA 1/70 (1.43%)", "Adverse Events 2:", " " ]

[ "INTERVENTION 1: ", " Supportive Care (Fluocinonide Cream)", " This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.", " All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks." ]

[ "INTERVENTION 1: ", " AeroForm Tissue Expander", " AeroForm Tissue Expansion inflation with carbon dioxide by remote control", " AeroForm Tissue Expander: The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander." ]

[ "INTERVENTION 1: ", " IUS Alone", "IUS alone imaging", "INTERVENTION 2: ", " Imagio (IUS+OA)", "IUS+OA imaging" ]

[ "Outcome Measurement: ", " Progression Free Survival (PFS)", " Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.", " Time frame: Baseline until disease progression (up to 3 years from first dose)", "Results 1: ", " Arm/Group Title: Sunitinib + Capecitabine", " Arm/Group Description: Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.", " Overall Number of Participants Analyzed: 221", " Median (95% Confidence Interval)", " Unit of Measure: months Independent radiology assessment: 5.5 (4.5 to 6.0)", " Investigator's assessment: 5.4 (4.4 to 5.8)", "Results 2: ", " Arm/Group Title: Capecitabine", " Arm/Group Description: Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.", " Overall Number of Participants Analyzed: 221", " Median (95% Confidence Interval)", " Unit of Measure: months Independent radiology assessment: 5.9 (5.4 to 7.6)", " Investigator's assessment: 5.5 (4.3 to 6.8)" ]

[ "Outcome Measurement: ", " Progression-Free Survival (PFS) Rate", " PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs). Percentage of participants who had not experienced progression or death by Week 16 is reported.", " Time frame: Baseline up to Week 16", "Results 1: ", " Arm/Group Title: Bosutinib", " Arm/Group Description: Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.", " Overall Number of Participants Analyzed: 73", " Measure Type: Number", " Unit of Measure: percentage of participants 39.6 (28.1 to 50.8)" ]

[ "Outcome Measurement: ", " pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy", " Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates.", " Time frame: Up to 5 years", "Results 1: ", " Arm/Group Title: FEC-75 Then Paclitaxel/Trastuzumab", " Arm/Group Description: Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies", " Overall Number of Participants Analyzed: 138", " Measure Type: Number", " Unit of Measure: percentage of participants 56.5 (47.8 to 64.9)", "Results 2: ", " Arm/Group Title: Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75", " Arm/Group Description: Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies", " Overall Number of Participants Analyzed: 142", " Measure Type: Number", " Unit of Measure: percentage of participants 54.2 (45.7 to 62.6)" ]

[ "Adverse Events 1:", " Total: 13/34 (38.24%)", " Anemia 3/34 (8.82%)", " Diarrhea 7/34 (20.59%)", " Nausea 2/34 (5.88%)", " Sepsis 1/34 (2.94%)", " Urinary tract infection 1/34 (2.94%)", " Alkaline phosphatase increased 1/34 (2.94%)", " Neutrophil count decreased 2/34 (5.88%)", " Dehydration 1/34 (2.94%)", " Headache 1/34 (2.94%)", " Thromboembolic event 1/34 (2.94%)" ]

[ "INTERVENTION 1: ", " SCPR Intervention", " Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.", " Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence", "INTERVENTION 2: ", " Control", " Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.", " Control: Web-based resource lists and text-based study adherence reminders" ]

[ "Adverse Events 1:", " Total: 1/41 (2.44%)", " Infection 1/41 (2.44%)", " Creatinine 1/41 (2.44%)", " Hypokalemia 1/41 (2.44%)", " Bicarbonate 1/41 (2.44%)", " SGOT 1/41 (2.44%)", " Alkaline Phosphatase value 1/41 (2.44%)", " Hyperbilirubineamia 1/41 (2.44%)", " Hypoalbuminemia 1/41 (2.44%)", " Leukocytes 1/41 (2.44%)", " Hemoglobin 1/41 (2.44%)", " Neutrophils 1/41 (2.44%)", " INR 1/41 (2.44%)", " PTT 1/41 (2.44%)", "Adverse Events 2:", " " ]

[ "Adverse Events 1:", " Total: 14/81 (17.28%)", " Neutropenia1/81 (1.23%)", " Cataract1/81 (1.23%)", " Ascites1/81 (1.23%)", " Gastritis Hemorrhagic1/81 (1.23%)", " Nausea1/81 (1.23%)", " Stomatitis2/81 (2.47%)", " Malaise1/81 (1.23%)", " Oedema1/81 (1.23%)", " Pain1/81 (1.23%)", " Pyrexia1/81 (1.23%)", " Infection2/81 (2.47%)", " Upper Limb Fracture1/81 (1.23%)", " Dehydration1/81 (1.23%)", " Hypercalcemia1/81 (1.23%)" ]

[ "Inclusion Criteria:", " To be included in this study, you must meet the following criteria:", " Adenocarcinoma of the breast confirmed by biopsy", " Female Patients >18 years of age", " Normal cardiac function", " Ability to perform activities of daily living with minimal assistance", " Chemotherapy naïve or have received prior chemotherapy > 5 years ago", " Adequate bone marrow, liver and kidney function", " Be informed of the investigational nature of this study", " Sign an informed consent form", " Sentinel lymph node and/or axillary dissection prior to enrollment", "Exclusion Criteria:", " You cannot participate in this study if any of the following apply to you:", " Life expectancy of < than 6 months", " History of significant heart disease", " Prior chemotherapy or hormonal therapy", " Concurrent Trastuzumab therapy", " History of significant psychiatric disorders", " History of active uncontrolled infection", " Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have." ]

[ "Inclusion Criteria:", " HER-2 overexpressing breast cancer", " Clinical stage 2-3B", " Normal ejection fraction", "Exclusion Criteria:", " Metastatic disease", " Low ejection fraction" ]

[ "Adverse Events 1:", " Total: 25/60 (41.67%)", " Anaemia * 1/60 (1.67%)", " Febrile neutropenia * 2/60 (3.33%)", " Idiopathic thrombocytopenic purpura * 1/60 (1.67%)", " Thrombocytopenia * 3/60 (5.00%)", " Cardiac failure * 1/60 (1.67%)", " Cardiac failure acute * 1/60 (1.67%)", " Cardiogenic shock * 1/60 (1.67%)", " Left ventricular dysfunction * 1/60 (1.67%)", " Anal fistula * 1/60 (1.67%)" ]

[ "Adverse Events 1:", " Total: 4/26 (15.38%)", " Febrile neutropenia * 1/26 (3.85%)", " Gastric volvulus * 20/26 (0.00%)", " General Malaise * 21/26 (3.85%)", " Hospitalisation for intrapleuric chemotherapy and thoracentesis * 21/26 (3.85%)", " Acute renal failure * 21/26 (3.85%)", "Adverse Events 2:", " Total: 1/28 (3.57%)", " Febrile neutropenia * 0/28 (0.00%)", " Gastric volvulus * 21/28 (3.57%)", " General Malaise * 20/28 (0.00%)", " Hospitalisation for intrapleuric chemotherapy and thoracentesis * 20/28 (0.00%)", " Acute renal failure * 20/28 (0.00%)" ]

[ "INTERVENTION 1: ", " Cohort A: Triple-negative Breast Cancer Patients", " Patients with triple-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.", "INTERVENTION 2: ", " Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients", " Patients with hormone receptor positive (ER and/or PR positive), HER negative breast cancer breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route." ]

[ "INTERVENTION 1: ", " Laser Therapy Alone", " therapist administered laser treatment", " laser: therapist administered laser", "INTERVENTION 2: ", " Mld Alone", " therapist administered manual lymphatic drainage", " manual lymphatic drainage: therapist administered massage therapy" ]

[ "INCLUSION CRITERIA (Disease Characteristics):", " Diagnosis of breast cancer", " Stage I or II disease", " No more than 10 positive lymph nodes", " First-time diagnosis", " Under the age of 50 at diagnosis", " Finished active treatment within the past 2 months", " English-speaking only", " Must live within 30 miles of Magee Women's Hospital, Pittsburgh, Pennsylvania", " INCLUSION CRITERIA (Patient Characteristics):", " Female patients only", " Must be able to communicate", " EXCLUSION CRITERIA (Patient Characteristics):", " Other prior malignancies except skin cancer", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics" ]

[ "INTERVENTION 1: ", " Pre-diagnosed Breast Cancer - Biopsy Confirmed", " Low-power microwave breast imaging system.", " Core needle biopsy performed 14 days before the microwave breast investigation", " Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump", "INTERVENTION 2: ", " Pre-diagnosed Breast Cyst", " Low-power microwave breast imaging system.", " No prior biopsy", " Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump" ]

[ "INTERVENTION 1: ", " Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)", " 6 mg/kg IMGN853 IV Q3W" ]

[ "INTERVENTION 1: ", " HER2-targeted PET/CT", " Pts with confirmed HER2- breast cancer will undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy." ]

[ "Adverse Events 1:", " Total: 4/31 (12.90%)", " Bleeding 1/31 (3.23%)", " Pain 2/31 (6.45%)", " Dehydration 1/31 (3.23%)", " Dyspnea 1/31 (3.23%)" ]

[ "Adverse Events 1:", " Total: 3/19 (15.79%)", " Febrile neutropenia 1/19 (5.26%)", " Colitis 1/19 (5.26%)", " Pain in extremity 0/19 (0.00%)", " Nephrolithiasis 0/19 (0.00%)", " Pulmonary embolism 1/19 (5.26%)", " Dyspnoea 0/19 (0.00%)", " Haematoma 0/19 (0.00%)", "Adverse Events 2:", " Total: 4/30 (13.33%)", " Febrile neutropenia 1/30 (3.33%)", " Colitis 0/30 (0.00%)", " Pain in extremity 1/30 (3.33%)", " Nephrolithiasis 1/30 (3.33%)", " Pulmonary embolism 0/30 (0.00%)", " Dyspnoea 1/30 (3.33%)", " Haematoma 1/30 (3.33%)" ]

[ "INTERVENTION 1: ", " Arm I", " Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.", " ONTAK: Given IV", " flow cytometry: Correlative studies", " immunohistochemistry staining method: Correlative studies", " enzyme-linked immunosorbent assay: Correlative studies", " laboratory biomarker analysis: Correlative studies", " protein expression analysis: Correlative studies" ]

[ "Outcome Measurement: ", " Disease-free Survival (DFS)", " Disease-free survival (DFS) for all patients regardless of randomization will be determined by patients' own physicians at the individual study sites during routine follow-up screening. This will occur every three months for the first 24 months after completion of primary therapies and every six months thereafter with clinical exam, and laboratory and radiographic surveillance. The primary objective of the study is disease-free survival (DFS) at 24 months.", " Time frame: Disease-free survival at 24 months", "Results 1: ", " Arm/Group Title: Herceptin + NeuVax Vaccine", " Arm/Group Description: Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year; the first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive vaccinations of NeuVax vaccine administered intradermally every 3 weeks for 6 total vaccinations, 30-120 minutes after completion of Herceptin infusion. The NeuVax vaccine series will begin immediately after completion of the third Herceptin infusion, but may be delayed to the fourth or fifth Herceptin infusion with prior approval from the PI. After completion of primary vaccine series, patients will receive NeuVax vaccine booster inoculations to be administered every 6 months x 4 for total treatment duration of 30 months.", " Overall Number of Participants Analyzed: 136", " Measure Type: Number", " Unit of Measure: Percentage of participants who survived 89.8", "Results 2: ", " Arm/Group Title: Herceptin + GM-CSF Only", " Arm/Group Description: Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year. The first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive inoculations of GM-CSF only (250mcg) administered intradermally every 3 weeks for 6 total inoculations, 30-120 minutes after completion of Herceptin infusion. The GM-CSF only inoculation series will begin immediately after completion of the third Herceptin infusion. After completion of six-inoculation primary vaccine series, patients will then receive a total of four GM-CSF only booster inoculations to be administered at 12, 18, 24, and 30 months from the date of the first Herceptin infusion.", " Overall Number of Participants Analyzed: 139", " Measure Type: Number", " Unit of Measure: Percentage of participants who survived 83.8" ]

[ "Outcome Measurement: ", " Percentage of Participants With Disease Free Survival at 5 Years", " Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.", " Time frame: From randomization until relapse or death or up to 5 years", "Results 1: ", " Arm/Group Title: Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)", " Arm/Group Description: Doxorubicin 60 mg/m IV bolus injection in combination with cyclophosphamide 600 mg/m IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m IV infusion every 3 weeks for another 4 cycles.", " Overall Number of Participants Analyzed: 1073", " Measure Type: Number", " Unit of Measure: percentage of participants 75.5 (72.8 to 78.2)", "Results 2: ", " Arm/Group Title: AC Followed by Docetaxel + Herceptin (AC→TH)", " Arm/Group Description: Doxorubicin 60 mg/m IV bolus injection in combination with cyclophosphamide 600 mg/m IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.", " Overall Number of Participants Analyzed: 1074", " Measure Type: Number", " Unit of Measure: percentage of participants 83.2 (80.9 to 85.4)" ]

[ "Inclusion Criteria:", " Survivors: Latina, has been diagnosed with breast cancer, speaks English or Spanish, has a Caregiver who is willing to participate.", " Caregivers: a primary caregiver for a Latina breast cancer survivor, speak English or Spanish", "Exclusion Criteria:", " Inability to understand spoken English and/or Spanish and/or", " Cognitive impairment that precludes informed consent (determined by the PIs or Co-Investigators who are mental health professionals)." ]

[ "INTERVENTION 1: ", " Multicomponent Intervention", " 1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.", "INTERVENTION 2: ", " Usual Care", " Care as usual with the medical oncologist." ]

[ "Inclusion Criteria:", " female patients 18-70 years of age;", " adenocarcinoma of the breast;", " previous invasive breast cancer if diagnosed >5 years before entering study;", " no evidence of metastatic disease.", "Exclusion Criteria:", " history of severe hypersensitivity reaction to Taxotere;", " previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane;", " treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years." ]

[ "Inclusion Criteria:", " Age 52-75 years old;", " Identification as Latina/Hispanic/Chicana female;", " Residence in Pilsen, Little Village, East Side or South Chicago;", " No history of health volunteerism;", " No history of breast cancer; and", " Lack of a mammogram within the last two years", "Exclusion Criteria:", " Not meeting all inclusion criteria;", " Women will be excluded if they participated in formative focus groups" ]

[ "Adverse Events 1:", " Total: 13/83 (15.66%)", " Cardiac failure congestive 1/83 (1.20%)", " Hypothyroidism 1/83 (1.20%)", " Nausea 2/83 (2.41%)", " Vomiting 2/83 (2.41%)", " Diarrhea 1/83 (1.20%)", " Gastrointestinal Haemorrhage 1/83 (1.20%)", " Asthenia 1/83 (1.20%)", " Hyperbilirubinaemia 1/83 (1.20%)", " Anal abscess 1/83 (1.20%)", " Dehydration 3/83 (3.61%)", " Decreased appetite 1/83 (1.20%)" ]

[ "Adverse Events 1:", " Total: 7/26 (26.92%)", " Febrile neutropenia 1/26 (3.85%)", " Neutropenia 0/26 (0.00%)", " Thrombocytopenia 0/26 (0.00%)", " Cardiac failure congestive 0/26 (0.00%)", " Extrasystoles 0/26 (0.00%)", " Nausea 1/26 (3.85%)", " Abdominal pain 0/26 (0.00%)", " Constipation 0/26 (0.00%)", " Gastrointestinal haemorrhage 0/26 (0.00%)", " Death - unknown cause 1/26 (3.85%)", " Thrombosis in device 0/26 (0.00%)", "Adverse Events 2:", " Total: 5/10 (50.00%)", " Febrile neutropenia 0/10 (0.00%)", " Neutropenia 0/10 (0.00%)", " Thrombocytopenia 1/10 (10.00%)", " Cardiac failure congestive 0/10 (0.00%)", " Extrasystoles 0/10 (0.00%)", " Nausea 0/10 (0.00%)", " Abdominal pain 0/10 (0.00%)", " Constipation 0/10 (0.00%)", " Gastrointestinal haemorrhage 0/10 (0.00%)", " Death - unknown cause 0/10 (0.00%)", " Thrombosis in device 0/10 (0.00%)" ]

[ "Outcome Measurement: ", " Concordance of Blue Dye and Lymphoseek", " The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.", " Time frame: Surgery after injections of Lymphoseek and blue dye", "Results 1: ", " Arm/Group Title: Intent-To-Treat", " Arm/Group Description: Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.", " Overall Number of Participants Analyzed: 133", " Overall Number of Units Analyzed", " Type of Units Analyzed: Lymph Nodes Measure Type: NumberNumber (95% Confidence Interval)Unit of Measure: Proportion of Lymph Nodes: 1.0000 (0.9840 to 1.0000)" ]

[ "Outcome Measurement: ", " Patient Benefit Rate at 12 Weeks", " Percentage of patients with patient benefit at week 12. Patient benefit was defined by the absence of central nervous system (CNS) disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in addition to no tumour-related worsening of the neurological signs and symptoms (NSS), no tumour-related increase in corticosteroid dosage and no progression of extra CNS disease according to RECIST 1.1", " Time frame: 12 weeks from randomisation", "Results 1: ", " Arm/Group Title: Afatinib Mono", " Arm/Group Description: Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.", " Overall Number of Participants Analyzed: 40", " Measure Type: Number", " Unit of Measure: percentage of participants 30.0 (16.6 to 46.5)", "Results 2: ", " Arm/Group Title: Afatinib+Vino", " Arm/Group Description: Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m administered intravenously on days 1, 8, 15 in a 3-weekly course.", " Overall Number of Participants Analyzed: 38", " Measure Type: Number", " Unit of Measure: percentage of participants 34.2 (19.6 to 51.4)" ]

[ "INTERVENTION 1: ", " Stratum 1: TAC + Bevacizumab", " HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.", "INTERVENTION 2: ", " Stratum 2: TCH + Bevacizumab", " HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks." ]

[ "INTERVENTION 1: ", " Triptorelin Plus Tamoxifen", " Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.", "INTERVENTION 2: ", " Triptorelin Plus Exemestane", " Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years." ]

[ "Outcome Measurement: ", " Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants", " PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.", " Time frame: Baseline up to approximately 34 months", "Results 1: ", " Arm/Group Title: Placebo Plus Nab-Paclitaxel", " Arm/Group Description: Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 451", " Median (95% Confidence Interval)", " Unit of Measure: Months 5.49 (5.32 to 5.59)", "Results 2: ", " Arm/Group Title: Atezolizumab Plus Nab-Paclitaxel", " Arm/Group Description: Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 451", " Median (95% Confidence Interval)", " Unit of Measure: Months 7.16 (5.59 to 7.46)" ]

[ "Outcome Measurement: ", " Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months", " PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.", " Time frame: From the date of randomization to 6-months on study", "Results 1: ", " Arm/Group Title: Ixabepilone 16 mg/m^2", " Arm/Group Description: ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest", " Overall Number of Participants Analyzed: 85", " Measure Type: Number", " Unit of Measure: Percentage of Participants 28.6 (18.9 to 38.9)", "Results 2: ", " Arm/Group Title: Ixabepilone 40 mg/m^2", " Arm/Group Description: ixabepilone 40 mg/m^2 every 3 weeks", " Overall Number of Participants Analyzed: 91", " Measure Type: Number", " Unit of Measure: Percentage of Participants 42.7 (31.5 to 53.5)" ]

[ "Inclusion Criteria:", " Metastatic adenocarcinoma of the breast (Stage IV)", " Actively receiving endocrine therapy for at least 6 weeks (with or without HER2 therapy)", " Minimum age 18 years", " ECOG Performance status of 0, 1 or 2", " Normal organ and marrow function as defined in the protocol", "Exclusion Criteria:", " Participants may not be receiving any other study agents", " Actively receiving chemotherapy (exclusive of hormonal or HER2 therapy ) within last 5 weeks", " Any statin therapy within the last 3 weeks", " Asian decent (including Filipino, Chinese, Japanese, Korean, Vietnamese or Asian-Indian origin)", " Concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketaconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors", " Conditions predisposing to renal failure secondary to rhabdomyolysis", " Recent history of heavy alcohol use as judged by the treating physician", " Known to be pregnant (testing not required) or nursing", " History of rhabdomyolysis on statin therapy", " Known history of Hepatitis C or active hepatitis B infection (baseline testing not required)", " Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements" ]

[ "Adverse Events 1:", " Total: 7/42 (16.67%)", " Febrile neutropenia 1/42 (2.38%)", " Left venrticular dysfunction 1/42 (2.38%)", " Cardiac valve disease 1/42 (2.38%)", " Diarrhoea 0/42 (0.00%)", " Abdominal pain 1/42 (2.38%)", " Colitis 0/42 (0.00%)", " Nausea 0/42 (0.00%)", " Vomiting 0/42 (0.00%)", " Pyrexia 0/42 (0.00%)", " Influenza like illness 1/42 (2.38%)", " Oedema peripheral 1/42 (2.38%)", " Fatigue 0/42 (0.00%)", "Adverse Events 2:", " Total: 7/42 (16.67%)", " Febrile neutropenia 0/42 (0.00%)", " Left venrticular dysfunction 1/42 (2.38%)", " Cardiac valve disease 0/42 (0.00%)", " Diarrhoea 0/42 (0.00%)", " Abdominal pain 0/42 (0.00%)", " Colitis 0/42 (0.00%)", " Nausea 0/42 (0.00%)", " Vomiting 0/42 (0.00%)", " Pyrexia 2/42 (4.76%)", " Influenza like illness 0/42 (0.00%)", " Oedema peripheral 0/42 (0.00%)", " Fatigue 0/42 (0.00%)" ]

[ "Adverse Events 1:", " Total: 21/209 (10.05%)", " Anaemia 0/209 (0.00%)", " Febrile neutropenia 0/209 (0.00%)", " Thrombocytopenia 0/209 (0.00%)", " Acute myocardial infarction 0/209 (0.00%)", " Cardiac failure 0/209 (0.00%)", " Diplopia 0/209 (0.00%)", " Gastric haemorrhage 0/209 (0.00%)", " Nausea 0/209 (0.00%)", " Oral pain 0/209 (0.00%)", " Vomiting 1/209 (0.48%)", " Mucosal inflammation 0/209 (0.00%)", " Pain 1/209 (0.48%)", "Adverse Events 2:", " Total: 29/216 (13.43%)", " Anaemia 2/216 (0.93%)", " Febrile neutropenia 2/216 (0.93%)", " Thrombocytopenia 2/216 (0.93%)", " Acute myocardial infarction 1/216 (0.46%)", " Cardiac failure 1/216 (0.46%)", " Diplopia 1/216 (0.46%)", " Gastric haemorrhage 1/216 (0.46%)", " Nausea 1/216 (0.46%)", " Oral pain 2/216 (0.93%)", " Vomiting 2/216 (0.93%)", " Mucosal inflammation 1/216 (0.46%)", " Pain 0/216 (0.00%)" ]

[ "Adverse Events 1:", " Total: 46/127 (36.22%)", " Febrile neutropenia 4/127 (3.15%)", " Neutropenia 1/127 (0.79%)", " Atrial fibrillation 2/127 (1.57%)", " Cardiac failure 0/127 (0.00%)", " Left ventricular dysfunction 4/127 (3.15%)", " Mitral valve disease 1/127 (0.79%)", " Myocardial ischaemia 1/127 (0.79%)", " Sinus tachycardia 1/127 (0.79%)", " Myocardial infarction 1/127 (0.79%)", " Adrenal haemorrhage 1/127 (0.79%)", "Adverse Events 2:", " Total: 28/124 (22.58%)", " Febrile neutropenia 2/124 (1.61%)", " Neutropenia 1/124 (0.81%)", " Atrial fibrillation 0/124 (0.00%)", " Cardiac failure 1/124 (0.81%)", " Left ventricular dysfunction 0/124 (0.00%)", " Mitral valve disease 0/124 (0.00%)", " Myocardial ischaemia 0/124 (0.00%)", " Sinus tachycardia 0/124 (0.00%)", " Myocardial infarction 0/124 (0.00%)", " Adrenal haemorrhage 0/124 (0.00%)" ]

[ "Inclusion Criteria:", " Female or male 18 years of age.", " Newly diagnosed ER-positive, HER2-negative breast cancer. ER-positive is defined as 1% immunohistochemical (IHC) staining of any intensity. HER2 test result is negative if a single test (or both tests) performed show:", " IHC 1+ or 0", " In situ hybridization negative based on:", " Single-probe average HER2 copy number < 4.0 signals/cell", " Dual-probe HER2/CEP17 ratio < 2 with an average HER2 copy number < 4.0 signals/cell.", " Patients with stage II-III breast cancer are eligible if they are deemed appropriate for neoadjuvant endocrine therapy by the referring or treating medical oncologist. Patients with stage I disease are eligible if they are deemed borderline candidates for breast conservation and the treating surgeon recommends preoperative therapy to increase the chances of breast conservation.", " Eastern Cooperative Oncology Group performance status and/or other performance status of 1.", " Female patients who:", " Are postmenopausal for at least 1 year before the screening visit, OR", " Are surgically sterile, OR", " If they are of childbearing potential, agree to practice 1 effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the ICF through 90 days (or longer, as mandated by local labeling [e.g., United Surgical Partners International, summary of product characteristics, etc.] after the last dose of the study drugs, OR", " Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condom should not be used together).", " Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:", " Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of the study drugs, OR", " Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient", " Agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of the study drugs.", " Screening clinical laboratory values as specified below:", " Bone marrow reserve consistent with: absolute neutrophil count 1.5 x 109/L, platelet count 100 x 109/L, and hemoglobin 9 g/dL (without transfusion) within 1 week preceding the administration of the study drugs;", " Hepatic status: Serum total bilirubin 1 x upper limit of normal (ULN; in the case of known Gilbert's syndrome, a higher serum total bilirubin [< 1.5 x ULN] is allowed), aspartate aminotransferase and alanine aminotransferase 1.5 x ULN, and alkaline phosphatase 1.5 x ULN;", " Renal status: Creatinine clearance 50 mL/min based on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour);", " Metabolic status: HbA1c < 7.0%, fasting serum glucose 130 mg/dL, and fasting triglycerides 300 mg/dL.", " Ability to swallow oral medications.", " Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.", " Negative serum pregnancy test within 7 days prior to the administration of the study drugs for female patients of childbearing potential.", " Patient must be accessible for treatment and follow-up.", " Patient must be willing to undergo breast biopsies as required by the study protocol.", "Exclusion Criteria:", " Any patient with metastatic disease.", " Other clinically significant comorbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise the patient's participation in the study.", " Known human immunodeficiency virus infection.", " Known hepatitis B surface antigen-positive or known or suspected active hepatitis C infection.", " Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of the protocol-specified treatment.", " Diagnosed or treated for another malignancy within 2 years before administration of the first dose of the study drugs or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.", " Breastfeeding or pregnant.", " Manifestations of malabsorption due to prior gastrointestinal surgery, gastrointestinal disease, or an unknown reason that may alter the absorption of TAK-228. Patients with enteric stomata are also excluded.", " Treatment with any investigational products within 2 weeks before administration of the first dose of the study drugs.", " Poorly controlled diabetes mellitus (defined as HbA1c > 7%). Patients with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in the study if all other inclusion criteria and none of the other exclusion criteria are met.", " History of any of the following within the last 6 months before administration of the first dose of the study drugs:", " Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures", " Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures", " Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, and ventricular tachycardia)", " Placement of a pacemaker for control of rhythm", " New York Heart Association Class III or IV heart failure", " Pulmonary embolism", " Significant active cardiovascular or pulmonary disease including:", " Uncontrolled hypertension (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg). Use of antihypertensive agents to control hypertension before week 1, day 1 is allowed.", " Pulmonary hypertension", " Uncontrolled asthma or O2 saturation < 90% by arterial blood gas analysis or pulse oximetry on room air", " Significant valvular disease, severe regurgitation, or stenosis by imaging independent of symptom control with medical intervention or history of valve replacement", " Medically significant (symptomatic) bradycardia", " History of arrhythmia requiring an implantable cardiac defibrillator", " Baseline QTc prolongation (e.g., repeated demonstration of QTc interval > 480 milliseconds or history of congenital long QT syndrome or torsades de pointes)", " Treatment with strong inhibitors and/or inducers of CYP3A4, CYP2C9, or CYP2C19 within 7 days preceding the first dose of the study drugs.", " Patients receiving systemic corticosteroids (either IV or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of the study drugs.", " Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of the study drugs.", " Patients unwilling or unable to comply with the study protocol.", " Patients previously treated with hormonal therapy (tamoxifen, AI) or PI3K, AKT, dual PI3K/mTOR, TORC1/2, or mTORC1 inhibitors.", " Patients who are currently being treated with cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) other than the trial therapy.", " Patients with hypersensitivity to mTOR inhibitors or tamoxifen." ]

[ "Inclusion Criteria:", " Postmenopausal status defined as history of at least 12 months without spontaneous menstrual bleeding or a documented hysterectomy and bilateral salpingo oophorectomy", " Breast density greater than 25%", " No hormone replacement therapy for at least six months prior to entry into this study", " Non-smokers.", "Exclusion Criteria:", " History of stroke, pulmonary embolism or deep vein thrombosis", " History of atherosclerotic heart disease", " Presence of any known hypercoagulable state either congenital (e.g., protein S deficiency) or acquired (e.g., corticosteroid treatment)", " Diabetes mellitus", " Uncontrolled hypertension (BP 140/90)", " Presence of a psychiatric condition that would interfere with adherence to the protocol." ]

[ "INTERVENTION 1: ", " FFDM and DBT", " FFDM exam and DBT scan on Siemens MAMMOMAT Inspiration", "INTERVENTION 2: ", " FFDM Only", "FFDM exam only" ]

[ "INTERVENTION 1: ", " Lidocaine Patch", " Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.", "INTERVENTION 2: ", " Placebo Patch", " Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day." ]

[ "Outcome Measurement: ", " Progression Free Survival (PFS)", " PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first.", " Time frame: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016)", "Results 1: ", " Arm/Group Title: Ipatasertib and Paclitaxel", " Arm/Group Description: Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.", " Overall Number of Participants Analyzed: 62", " Median (90% Confidence Interval)", " Unit of Measure: Months 6.18 (4.57 to 7.33)", "Results 2: ", " Arm/Group Title: Placebo and Paclitaxel", " Arm/Group Description: Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.", " Overall Number of Participants Analyzed: 62", " Median (90% Confidence Interval)", " Unit of Measure: Months 4.93 (3.58 to 5.36)" ]

[ "Outcome Measurement: ", " Percentage of Participants With Total Pathological Complete Response (tpCR) Assessed Based on Tumor Samples", " tpCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( that is [i.e.], ypT0/is, ypN0 in the American Joint Committee on Cancer [AJCC] staging system, 7th edition). Percentage of participants with tpCR was reported.", " Time frame: Pre-surgery (within 6 weeks after neoadjuvant therapy; up to approximately 6 months)", "Results 1: ", " Arm/Group Title: TCH + P", " Arm/Group Description: Participants received pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion, trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 milligrams per square meter (mg/m^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter* minute (mg/mL*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).", " Overall Number of Participants Analyzed: 221", " Measure Type: Number", " Unit of Measure: Percentage of Participants 56.1 (49.29 to 62.76)", "Results 2: ", " Arm/Group Title: T-DM1 + P", " Arm/Group Description: Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).", " Overall Number of Participants Analyzed: 223", " Measure Type: Number", " Unit of Measure: Percentage of Participants 44.4 (37.76 to 51.18)" ]

[ "Adverse Events 1:", " Total: 7/52 (13.46%)", " Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 0/52 (0.00%)", " Atrial Fibrillation * 1/52 (1.92%)", " Sepsis * 1/52 (1.92%)", " Muscle weakness upper limb * 1/52 (1.92%)", " Dizziness * 1/52 (1.92%)", " Seizure * 1/52 (1.92%)", " Nervous system disorders - Other, specify * [1]1/52 (1.92%)", "Adverse Events 2:", " Total: 1/30 (3.33%)", " Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1/30 (3.33%)", " Atrial Fibrillation * 0/30 (0.00%)", " Sepsis * 0/30 (0.00%)", " Muscle weakness upper limb * 0/30 (0.00%)", " Dizziness * 0/30 (0.00%)", " Seizure * 0/30 (0.00%)", " Nervous system disorders - Other, specify * [1]0/30 (0.00%)" ]

[ "Adverse Events 1:", " Total: 16/76 (21.05%)", " Hemoglobin 0/76 (0.00%)", " Left ventricular systolic function 1/76 (1.32%)", " Hypertension 0/76 (0.00%)", " Dehydration 1/76 (1.32%)", " Diarrhea 1/76 (1.32%)", " Hemorrhage, GI - stomach 0/76 (0.00%)", " Perforation, GI - colon 1/76 (1.32%)", " Ulcer, GI - stomach 0/76 (0.00%)", " Pain- head/headache 3/76 (3.95%)", " Pain- back 2/76 (2.63%)", "Adverse Events 2:", " Total: 5/29 (17.24%)", " Hemoglobin 1/29 (3.45%)", " Left ventricular systolic function 0/29 (0.00%)", " Hypertension 1/29 (3.45%)", " Dehydration 1/29 (3.45%)", " Diarrhea 0/29 (0.00%)", " Hemorrhage, GI - stomach 1/29 (3.45%)", " Perforation, GI - colon 0/29 (0.00%)", " Ulcer, GI - stomach 1/29 (3.45%)", " Pain- head/headache 0/29 (0.00%)", " Pain- back 0/29 (0.00%)" ]

[ "INTERVENTION 1: ", " Letrozole, Breast Enhancement, Safety", " Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI." ]

[ "INTERVENTION 1: ", " Healthy Volunteers", " Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.", " Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:", " an IV line is placed by nurse,", " patient is placed in the 4 T MRI scanner at CMRR,", " initial scout images and manual linear shims are adjusted,", " Pre-contrast SWIFT T1 weighted images and T1 map are obtained,", " continuous SWIFT acquisition begins immediately before contrast injection,", " contrast injection,", " continuous SWIFT acquisition continues for 12 min after contrast,", " late enhancement images may also be obtained.", " 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods.", "INTERVENTION 2: ", " Breast Cancer Patients", " Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.", " Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:", " an IV line is placed by nurse,", " patient is placed in the 4 T MRI scanner at CMRR,", " initial scout images and manual linear shims are adjusted,", " Pre-contrast SWIFT T1 weighted images and T1 map are obtained,", " continuous SWIFT acquisition begins immediately before contrast injection,", " contrast injection,", " continuous SWIFT acquisition continues for 12 min after contrast,", " late enhancement images may also be obtained.", " 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar" ]

[ "Adverse Events 1:", " Total: 116/396 (29.29%)", " Anaemia 3/396 (0.76%)", " Febrile neutropenia 20/396 (5.05%)", " Granulocytopenia 1/396 (0.25%)", " Leukopenia 1/396 (0.25%)", " Neutropenia 19/396 (4.80%)", " Atrial fibrillation 3/396 (0.76%)", " Cardiac failure congestive 0/396 (0.00%)", " Coronary artery disease 0/396 (0.00%)", " Left ventricular dysfunction 7/396 (1.77%)", " Myocardial infarction 3/396 (0.76%)", "Adverse Events 2:", " Total: 160/408 (39.22%)", " Anaemia 3/408 (0.74%)", " Febrile neutropenia 46/408 (11.27%)", " Granulocytopenia 0/408 (0.00%)", " Leukopenia 0/408 (0.00%)", " Neutropenia 18/408 (4.41%)", " Atrial fibrillation 0/408 (0.00%)", " Cardiac failure congestive 2/408 (0.49%)", " Coronary artery disease 1/408 (0.25%)", " Left ventricular dysfunction 6/408 (1.47%)", " Myocardial infarction 0/408 (0.00%)" ]

[ "INTERVENTION 1: ", " ARM 1 Daily Boost", " Radiation Therapy", " Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.", " Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.", "INTERVENTION 2: ", " ARM 2 Weekly Boost", " Radiation Therapy", " Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.", " Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed." ]

[ "INTERVENTION 1: ", " 0.005% Estriol Vaginal Gel", " Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration", "INTERVENTION 2: ", " Placebo Vaginal Gel", " Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration", "Placebo" ]

[ "Outcome Measurement: ", " Objective Response Rate (ORR), Defined as the Proportion of Patients Who Have Had a Partial Response (PR) or Complete Response (CR) (RECIST 1.1 Based) Within the First 6 Months After Initiation of Therapy With Trametinib", " Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", " Time frame: 6 months", "Results 1: ", " Arm/Group Title: Treatment (Trametinib, Akt Inhibitor GSK2141795)", " Arm/Group Description: PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.", " PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.", " Akt Inhibitor GSK2141795: Given PO", " Laboratory Biomarker Analysis: Correlative studies", " Trametinib: Given PO", " Overall Number of Participants Analyzed: 37", " Measure Type: Count of Participants", " Unit of Measure: Participants 2 5.4%" ]

[ "Outcome Measurement: ", " Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy", " A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel.", " Time frame: Week 26", "Results 1: ", " Arm/Group Title: Trastuzumab", " Arm/Group Description: Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.", " Overall Number of Participants Analyzed: 26", " Measure Type: Number", " Unit of Measure: percentage of participants 54.0", "Results 2: ", " Arm/Group Title: Lapatinib", " Arm/Group Description: Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.", " Overall Number of Participants Analyzed: 29", " Measure Type: Number", " Unit of Measure: percentage of participants 45.0" ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed adenocarcinoma of the breast", " Bilateral synchronous breast tumors allowed", " Any nodal status or tumor size allowed", " No stage IV disease", " HER2/neu-positive disease", " 3+ by IHC OR FISH-amplified", " Hormone receptor status not specified", " PATIENT CHARACTERISTICS:", " Male or female", " Menopausal status not specified", " ECOG performance status 0-1", " Absolute neutrophil count 1,000/mm³", " Platelet count 100,000/mm³", " Bilirubin 1.1 mg/dL", " SGOT or SGPT 2.5 times upper limit of normal (ULN)", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective barrier contraception during and after completion of study therapy", " LVEF 50% by MUGA scan", " No peripheral neuropathy > grade 1", " No active second malignancy within the past 5 years except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix", " No known allergy or hypersensitivity to doxorubicin hydrochloride, cyclophosphamide, paclitaxel, or other drugs formulated in Cremophor EL", " No psychiatric illness or concurrent medical conditions that would preclude study treatment", " No other conditions, including any of the following:", " Unstable angina", " Congestive heart failure", " Myocardial infarction within the past 12 months", " High-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade AV block, or supraventricular arrhythmias that are not adequately controlled)", " No QT prolongation (> 500 ms)", " No active unresolved infections", " No sensitivity to E. coli derived proteins", " PRIOR CONCURRENT THERAPY:", " Prior hormonal therapy for chemoprevention allowed", " No prior trastuzumab (Herceptin®)", " No prior anthracyclines", " No concurrent hormonal therapy, including hormonal contraception (e.g., birth control pills or ovarian hormonal or replacement therapy)", " No other concurrent chemotherapy, radiotherapy, immunotherapy, or biotherapy for breast cancer", " No concurrent drugs that may prolong the QT" ]

[ "INTERVENTION 1: ", " Afatinib Mono", " Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.", "INTERVENTION 2: ", " Afatinib+Vino", " Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course." ]

[ "INTERVENTION 1: ", " Active Control Group", " Health Education Active Control Group", "INTERVENTION 2: ", " My Surgical Success Treatment Group", " My Surgical Success Intervention Group" ]

[ "INTERVENTION 1: ", " All Study Participants, PA Compression Image Sets", " All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.", "INTERVENTION 2: ", " All Study Participants, TC Compression Image Sets", " All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers." ]

[ "INTERVENTION 1: ", " Single Drain", " Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.", " Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.", " Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.", " Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.", "INTERVENTION 2: ", " Double Drain", " Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.", " Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.", " Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.", " Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography." ]

[ "INTERVENTION 1: ", " Overall Population", " Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population." ]

[ "INTERVENTION 1: ", " Molecular Breast Imaging", " Molecular breast imaging performed after injection of 4 mCi Tc-99m sestamibi and again after 8 mCi Tc-99m sestamibi." ]

[ "Adverse Events 1:", " Total: 8/29 (27.59%)", " Hemorrhage - Nose 1/29 (3.45%)", " Left Ventricular Systolic Dysfunction 1/29 (3.45%)", " Vomiting 1/29 (3.45%)", " Esophagitis 1/29 (3.45%)", " Pain - Abdomen 1/29 (3.45%)", " Pain - Chest 1/29 (3.45%)", " Infection - Skin 1/29 (3.45%)", " Infection - Sepsis 2/29 (6.90%)", " Creatinine 1/29 (3.45%)", " Wound Complication, Non-Infectious 1/29 (3.45%)" ]

[ "Adverse Events 1:", " Total: 8/29 (27.59%)", " Leukopenia [1]1/29 (3.45%)", " Thrombocytopenia [1]1/29 (3.45%)", " Abscess [1]1/29 (3.45%)", " Breast Abscess 1/29 (3.45%)", " Fever/Sepsis [1]1/29 (3.45%)", " Neutropenic Fever [2]1/29 (3.45%)", " Peripheral Neuropathy [1]1/29 (3.45%)", " Seizure/Syncope [1]1/29 (3.45%)", " Hematuria [1]1/29 (3.45%)", " UTI [1]1/29 (3.45%)", " Shortness of breath [1]1/29 (3.45%)" ]

[ "INTERVENTION 1: ", " Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo", " Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).", "INTERVENTION 2: ", " Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg", " Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD." ]

[ "INTERVENTION 1: ", " Phase I: Cyclophosphamide, Doxil, Trastuzumab", " Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.", " pegylated liposomal doxorubicin hydrochloride: Given IV", " cyclophosphamide: Given orally", " trastuzumab: Given IV" ]

[ "INTERVENTION 1: ", " Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2", " Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.", "INTERVENTION 2: ", " Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2", " Cohort 2: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 140mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days." ]

[ "Adverse Events 1:", " Total: 7/15 (46.67%)", " Cardiac arrest * 1/15 (6.67%)", " Chest pain - cardiac * 1/15 (6.67%)", " Diarrhea * 1/15 (6.67%)", " Duodenal hemorrhage * 1/15 (6.67%)", " Fatigue * 1/15 (6.67%)", " Fever * 1/15 (6.67%)", " Sudden death NOS * 1/15 (6.67%)", " Sepsis * 1/15 (6.67%)", " Skin infection * 1/15 (6.67%)", " Neutrophil count decreased * 1/15 (6.67%)", " Platelet count decreased * 1/15 (6.67%)" ]

[ "Adverse Events 1:", " Total: 69/258 (26.74%)", " Anaemia 3/258 (1.16%)", " Febrile neutropenia 13/258 (5.04%)", " Neutropenia 5/258 (1.94%)", " Thrombocytopenia 1/258 (0.39%)", " Atrial fibrillation 0/258 (0.00%)", " Mitral valve incompetence 1/258 (0.39%)", " Pericardial effusion 0/258 (0.00%)", " Sinus tachycardia 0/258 (0.00%)", " Abdominal pain 3/258 (1.16%)", " Abdominal pain upper 1/258 (0.39%)", " Colitis 1/258 (0.39%)", "Adverse Events 2:", " Total: 64/224 (28.57%)", " Anaemia 2/224 (0.89%)", " Febrile neutropenia 4/224 (1.79%)", " Neutropenia 1/224 (0.45%)", " Thrombocytopenia 0/224 (0.00%)", " Atrial fibrillation 1/224 (0.45%)", " Mitral valve incompetence 0/224 (0.00%)", " Pericardial effusion 2/224 (0.89%)", " Sinus tachycardia 1/224 (0.45%)", " Abdominal pain 3/224 (1.34%)", " Abdominal pain upper 0/224 (0.00%)", " Colitis 0/224 (0.00%)" ]

[ "Adverse Events 1:", " Total: 27/50 (54.00%)", " Febrile neutropenia * 4/50 (8.00%)", " Anaemia * 1/50 (2.00%)", " Neutropenia * 1/50 (2.00%)", " Cardiac failure * 1/50 (2.00%)", " Diarrhoea * 1/50 (2.00%)", " Gastritis * 1/50 (2.00%)", " Nausea * 1/50 (2.00%)", " Oesophagitis * 1/50 (2.00%)", " Pyrexia * 7/50 (14.00%)", " Mucosal inflammation * 1/50 (2.00%)", " Drug hypersensitivity * 1/50 (2.00%)", " Cellulitis * 2/50 (4.00%)" ]

[ "Adverse Events 1:", " Total: 158/482 (32.78%)", " Anaemia 7/482 (1.45%)", " Disseminated intravascular coagulation 1/482 (0.21%)", " Lymphadenopathy 0/482 (0.00%)", " Neutropenia 0/482 (0.00%)", " Thrombocytopenia 2/482 (0.41%)", " Anaemia 28/482 (1.66%)", " Disseminated intravascular coagulation 21/482 (0.21%)", " Febrile neutropenia 21/482 (0.21%)", " Lymphadenopathy 20/482 (0.00%)", " Neutropenia 20/482 (0.00%)", "Adverse Events 2:", " Total: 37/238 (15.55%)", " Anaemia 2/238 (0.84%)", " Disseminated intravascular coagulation 0/238 (0.00%)", " Lymphadenopathy 1/238 (0.42%)", " Neutropenia 1/238 (0.42%)", " Thrombocytopenia 0/238 (0.00%)", " Anaemia 22/238 (0.84%)", " Disseminated intravascular coagulation 20/238 (0.00%)", " Febrile neutropenia 21/238 (0.42%)", " Lymphadenopathy 21/238 (0.42%)", " Neutropenia 21/238 (0.42%)" ]

[ "Adverse Events 1:", " Total: 15/48 (31.25%)", " Anemia * 1/48 (2.08%)", " Cardiac failure congestive * 1/48 (2.08%)", " Constipation * 2/48 (4.17%)", " Esophagitis * 1/48 (2.08%)", " Gastrointestinal hemorrhage * 1/48 (2.08%)", " Non-Cardiac chest pain * 1/48 (2.08%)", " Pain * 1/48 (2.08%)", " Cholecystitis * 1/48 (2.08%)", " Diverticulitis * 1/48 (2.08%)", " Cellulitis * 1/48 (2.08%)", " Gastroenteritis * 1/48 (2.08%)" ]

[ "Outcome Measurement: ", " Tumor Response", " Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (\"respond\"), stay the same (\"stable\"), or worsen (\"progression\") during treatment.", " Time frame: baseline to measured progressive disease", "Results 1: ", " Arm/Group Title: Dose Level 1", " Arm/Group Description: Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.", " Overall Number of Participants Analyzed: 6", " Measure Type: Number", " Unit of Measure: participants Complete Response: 0", " Partial Response: 0", " Long Stable Disease: 1", " Stable Disease: 1", " Progressive Disease: 2", "Not Evaluable: 2", "Results 2: ", " Arm/Group Title: Dose Level 2", " Arm/Group Description: Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.", " Overall Number of Participants Analyzed: 62", " Measure Type: Number", " Unit of Measure: participants Complete Response: 1", " Partial Response: 4", " Long Stable Disease: 4", " Stable Disease: 16", " Progressive Disease: 32", "Not Evaluable: 5" ]

[ "Adverse Events 1:", " Total: 2/4 (50.00%)", " Abdominal pain 0/4 (0.00%)", " Disease progression 0/4 (0.00%)", " Dehydration 2/4 (50.00%)", " Hyponatraemia 1/4 (25.00%)", " Metastasis to central nervous system 1/4 (25.00%)", " Oesophageal adenocarcinoma 0/4 (0.00%)", " Intracranial hypotension 0/4 (0.00%)", " Pneumothorax 0/4 (0.00%)", " Dyspnoea 0/4 (0.00%)", " Hypoxia 0/4 (0.00%)", "Adverse Events 2:", " Total: 1/3 (33.33%)", " Abdominal pain 0/3 (0.00%)", " Disease progression 0/3 (0.00%)", " Dehydration 0/3 (0.00%)", " Hyponatraemia 0/3 (0.00%)", " Metastasis to central nervous system 0/3 (0.00%)", " Oesophageal adenocarcinoma 0/3 (0.00%)", " Intracranial hypotension 0/3 (0.00%)", " Pneumothorax 1/3 (33.33%)", " Dyspnoea 0/3 (0.00%)", " Hypoxia 0/3 (0.00%)" ]

[ "INTERVENTION 1: ", " ChemoRT", " Concurrent Carboplatin and Radiotherapy", " Carboplatin: IV, weekly for 6 weeks, AUC of 2.0", " 3D-RT or IMRT: From week 2 to week 4 in the 6-week Carboplatin treatment: Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy" ]

[ "INTERVENTION 1: ", " High-dose Chemotherapy", " Carboplatin + Cyclophosphamide + Thiotepa", " Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.", " Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.", " Stem Cell Transplant : Stem Cell Transplant on Day 0.", " Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion." ]

[ "Outcome Measurement: ", " Change From Baseline in Mean Duration of the QTc Interval", " The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The corrected QT interval was calculated using Fridericia's correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QTcF intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QTcF interval was subtracted from the average QTcF intervals to create a baseline-adjusted average QTcF interval.", " Time frame: Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.", "Results 1: ", " Arm/Group Title: T-DM1", " Arm/Group Description: Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.", " Overall Number of Participants Analyzed: 51", " Mean (Standard Deviation)", " Unit of Measure: milliseconds Cycle 1, Day 1, 15 minutes post-dose [N=44]: 1.2 (8.3)", " Cycle 1, Day 1, 60 minutes post-dose [N=45]: -1.0 (6.3)", " Cycle 1, Day 8 [N=43]: -4.0 (13.4)", " Cycle 3, Day 1, 15 minutes pre-dose [N=35]: -0.1 (10.1)", " Cycle 3, Day 1, 15 minutes post-dose [N=37]: 4.7 (9.6)", " Cycle 3, Day 1, 60 minutes post-dose [N=37]: 4.7 (10.9)" ]

[ "INTERVENTION 1: ", " ARM 1 Daily Boost", " Radiation Therapy", " Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.", " Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.", "INTERVENTION 2: ", " ARM 2 Weekly Boost", " Radiation Therapy", " Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.", " Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed." ]

[ "INTERVENTION 1: ", " 0.005% Estriol Vaginal Gel", " Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration", "INTERVENTION 2: ", " Placebo Vaginal Gel", " Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration", "Placebo" ]

[ "Adverse Events 1:", " Total: 20/70 (28.57%)", " NAUSEA 2/70 (2.86%)", " VOMITING 1/70 (1.43%)", " DIARRHOEA 2/70 (2.86%)", " ABDOMINAL PAIN 1/70 (1.43%)", " ABDOMINAL PAIN LOWER 1/70 (1.43%)", " FATIGUE 2/70 (2.86%)", " PYREXIA 1/70 (1.43%)", " OEDEMA PERIPHERAL 1/70 (1.43%)", " GENERAL PHYSICAL HEALTH DETERIORATION 3/70 (4.29%)", " PNEUMONIA 1/70 (1.43%)", " SINUSITIS 1/70 (1.43%)", " LOBAR PNEUMONIA 1/70 (1.43%)", "Adverse Events 2:", " " ]

[ "Adverse Events 1:", " Total: 0/3 (0.00%)", " Febrile Neutropenia * 0/3 (0.00%)", " Neutropenia * 0/3 (0.00%)", " Sudden Death * 0/3 (0.00%)", " Bacterial Infection * 0/3 (0.00%)", " Bronchitis * 0/3 (0.00%)", " Sepsis * 0/3 (0.00%)", " Lymphoedema * 0/3 (0.00%)", "Adverse Events 2:", " Total: 6/41 (14.63%)", " Febrile Neutropenia * 1/41 (2.44%)", " Neutropenia * 1/41 (2.44%)", " Sudden Death * 1/41 (2.44%)", " Bacterial Infection * 1/41 (2.44%)", " Bronchitis * 1/41 (2.44%)", " Sepsis * 1/41 (2.44%)", " Lymphoedema * 1/41 (2.44%)" ]

[ "INTERVENTION 1: ", " Arm 1 (Paclitaxel, Carboplatin)", " Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.", " Paclitaxel: Given IV", " Carboplatin: Given IV", " Doxorubicin: Given IV", " Cyclophosphamide: Given IV", "INTERVENTION 2: ", " Arm 2 (Veliparib, Paclitaxel, Carboplatin)", " Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.", " Paclitaxel: Given IV", " Carboplatin: Given IV", " Doxorubicin: Given IV", " Cyclophosphamide: Given IV", " Veliparib: Given PO" ]

[ "INTERVENTION 1: ", " Treatment (Enzyme Inhibitor Therapy)", " Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity." ]

[ "INTERVENTION 1: ", " Treatment (Vorinostat, AI Therapy)", " Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.", " vorinostat: Given PO", " anastrozole: Given PO", " letrozole: Given PO", " exemestane: Given PO", " positron emission tomography: Correlative studies", " F-18 16 alpha-fluoroestradiol: Correlative studies", " fludeoxyglucose F 18: Correlative studies", " laboratory biomarker analysis: Correlative studies" ]

[ "INTERVENTION 1: ", " Fulvestrant 250 mg + Tipifarnib 300 mg", " Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity" ]

[ "Outcome Measurement: ", " Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment", " IRF assessed PFS was defined as time (in months) from randomization until the date of first documented radiologic progressive disease per response evaluation criteria in solid tumors (RECIST) version 1.1 or death from any cause, whichever occurs first. As per RECIST v1.1, progression defined as 1) for target lesions: at least a 20% increase in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), the absolute increase in the sum has to be at least 5 millimeter (mm); 2) for non-target lesions: unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions; 3) and/or appearance of one or more new lesions. The analysis was performed by Kaplan-Meier method.", " Time frame: Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 months)", "Results 1: ", " Arm/Group Title: Talazoparib", " Arm/Group Description: Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.", " Overall Number of Participants Analyzed: 287", " Median (95% Confidence Interval)", " Unit of Measure: months 8.6 (7.2 to 9.3)", "Results 2: ", " Arm/Group Title: Physician's Choice Treatment", " Arm/Group Description: Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.", " Overall Number of Participants Analyzed: 144", " Median (95% Confidence Interval)", " Unit of Measure: months 5.6 (4.2 to 6.7)" ]

[ "Outcome Measurement: ", " Best Overall Response of Everolimus and Exemestane Treatment in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer", " The best Overall Response (OR) for each patient is determined from the sequence of investigator overall lesion responses according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.). To be assigned a best OR of Complete Responese (CR) at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best OR of Partial Response (PR) at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required.The Overall Response Rate (ORR) was defined as the proportion of patients with a best OR of confirmed CR or PR by week 48.", " Time frame: At 48 weeks", "Results 1: ", " Arm/Group Title: Everolimus and Exemestane", " Arm/Group Description: Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.", " Overall Number of Participants Analyzed: 49", " Measure Type: Number", " Unit of Measure: participants Patients with measurable disease at baseline: 39", " Patients with non-measurable disease at baseline: 10", " Best at WK 48 - Complete Response (CR): 0", " Best at WK 48 - Partial Response (PR): 7", " Best at WK 48 - Stable Disease (SD): 18", " Best at WK 48 - Progressive Disease (PD): 15", "Unknown: 1", "Missing: 8" ]

[ "Inclusion Criteria:", " Females with histological/cytological confirmation of breast cancer.", " Subjects with a measurable lesion or bone lesions", "Exclusion Criteria:", " Previous radiotherapy within 6 weeks", " Significant cardiac events, arrhythmias or other cardiac conditions" ]

[ "Inclusion Criteria:", " Females with histological/cytological confirmation of breast cancer.", " Subjects with a measurable lesion or bone lesions", "Exclusion Criteria:", " Previous radiotherapy within 6 weeks", " Significant cardiac events, arrhythmias or other cardiac conditions" ]

[ "Adverse Events 1:", " Total: 15/31 (48.39%)", " Intracardiac Thrombus 1/31 (3.23%)", " Diarrhoea 2/31 (6.45%)", " Nausea 2/31 (6.45%)", " Vomiting 2/31 (6.45%)", " Ascites 0/31 (0.00%)", " Ileus 1/31 (3.23%)", " Small Intestinal Obstruction 1/31 (3.23%)", " Multi-Organ Failure 0/31 (0.00%)", " Sepsis 1/31 (3.23%)", " Weight Decreased 1/31 (3.23%)", " Dehydration 2/31 (6.45%)", " Hypokalaemia 0/31 (0.00%)", "Adverse Events 2:", " Total: 4/31 (12.90%)", " Intracardiac Thrombus 0/31 (0.00%)", " Diarrhoea 0/31 (0.00%)", " Nausea 0/31 (0.00%)", " Vomiting 0/31 (0.00%)", " Ascites 1/31 (3.23%)", " Ileus 0/31 (0.00%)", " Small Intestinal Obstruction 0/31 (0.00%)", " Multi-Organ Failure 1/31 (3.23%)", " Sepsis 0/31 (0.00%)", " Weight Decreased 0/31 (0.00%)", " Dehydration 0/31 (0.00%)", " Hypokalaemia 1/31 (3.23%)" ]

[ "Adverse Events 1:", " Total: 3/49 (6.12%)", " Neutrophils/ANC *1/49 (2.04%)", " Leukocytes *1/49 (2.04%)", " Hypocalcemia *1/49 (2.04%)", " Febrile neutropenia *1/49 (2.04%)", " Left Ventricular Systolic Dysfunction *1/49 (2.04%)", " Constipation *1/49 (2.04%)", " Mucositis-oral *1/49 (2.04%)", " Infection-oral thrush *1/49 (2.04%)", " rash *1/49 (2.04%)" ]

[ "Inclusion Criteria:", " Patients with histologic confirmation of invasive, but non-inflammatory carcinoma of the breast.", " Stage I (T1N0) are not eligible for the neo-adjuvant portion of the protocol.", " High-risk patients (patients with any of the following: high proliferation rate - Ki67 >35% or poorly differentiated tumors (black's modified grade 3); ER/PR negative; lymphovascular invasion) with stage I disease are eligible for adjuvant therapy.", " Patients with pure mucinous carcinomas, tubular carcinomas or pure medullary carcinomas are eligible if the patient's tumor is larger than 3 cm in size or if the patient has tumor involvement of the lymph nodes (>2mm).", " Patients with bilateral breast cancers are eligible.", " Patients with pN2a (metastasis in four to nine axillary lymph nodes) are eligible as are patients with pN3a (ten or more axillary lymph nodes). Patients with infraclavicular lymph node involvement are NOT eligible.", " Patients must have clinically measurable disease to be treated in the neoadjuvant setting. This includes patients with a non-palpable primary who have histologically proven lymph node (LN) involvement that is clinically palpable and measurable by ultrasound", " Histologic confirmation of invasive tumor will be done by core needle biopsy for patients with intact primary tumors. If patients have undergone adequate core biopsy prior to evaluation at MDACC, repeat core biopsy is optional.", " Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.", " Patients with a prior history of breast cancer are eligible if the current primary breast cancer is of a higher stage than the original breast cancer and the patient has not received any of the current study medications including past doxorubicin.", " Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of > 1,500/mm3, and platelet count > 100,000/mm3. Patients must have adequate liver function with a bilirubin within normal laboratory values. Transaminases (SGPT) may be up to 2.5x upper limit of normal (ULN) if alkaline phosphatase is < ULN or alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN.", " In addition, patients should have adequate renal function, defined as a serum creatinine < 2.5 mg% and/or creatinine clearance greater than 51 ml/min as calculated by Cockcroft and Gault Equation: Cockcroft and Gault Equation: Creatinine clearance for males = {(140 - age [yrs])(body weight [kg])}/{(72) (serum creatinine [mg/dL])}. Creatinine clearance for females = 0.85 x male value", " Patients who had surgical therapy prior to referral will be eligible for randomization to systemic chemotherapy administered in the adjuvant setting.", " Patients who have overexpression of the her-2/neu oncogene are eligible for the study.", "Exclusion Criteria:", " Patients with N2 (clinical staging) or N3 (clinical staging) nodal disease, inflammatory breast cancer, or metastatic disease are not eligible. This includes patients with infraclavicular and/or supraclavicular lymph node involvement. Patients with pN2a (metastasis in four to nine axillary lymph nodes) are eligible.", " Patients with pN2b (metastasis in clinically apparent internal mammary lymph nodes in the absence of axillary lymph node metastasis) are not eligible. Patients with T4 lesions in the neoadjuvant setting are not eligible. Patients with limited T4 lesions in the adjuvant setting (for example, focal extension into the skin with negative margins) are eligible.", " Severe hypersensitivity reactions to agents formulated in either cremophor or polysorbate 80 must be excluded. Patients with hypersensitivity reactions to any of the study medications must be excluded.", " Those patients with history of other malignancies will be excluded, except non-melanoma skin cancer and non-invasive cervical cancer.", " Patients with uncompensated congestive heart failure are not eligible. Patients with myocardial infarction within the past 12 months are ineligible.", " Patients who are pregnant or lactating are not eligible. Women of childbearing potential must have a negative pregnancy test prior to initiation of chemotherapy. Women of childbearing potential who will not use a reliable and appropriate contraceptive method during the study are not eligible.", " Patients who have had an organ allograft are ineligible.", " Patients with serious concurrent infections are ineligible.", " Sexually active male patients unwilling to practice contraception during the study are ineligible.", " Patients with pre-existing peripheral neuropathy > grade 1." ]

[ "Inclusion Criteria:", " Histologically documented, incurable, locally advanced or metastatic breast cancer", " Evaluable or measurable HER2-positive disease", " History of progression during or within 60 days after treatment with any prior trastuzumab-containing chemotherapy regimen for HER2-positive breast cancer", " Previous treatment with chemotherapy for MBC", " Granulocyte count 1,500/μL, platelet count 100,000/μL, and hemoglobin 9 g/dL", " Serum bilirubin 1.5 mg/dL; AST, ALT, and alkaline phosphatase 2.5 × upper limit of normal (ULN) except for: Patients with hepatic metastases: ALT and AST 5 × ULN Patients with hepatic and/or bone metastases: alkaline phosphatase 5 × ULN", " Serum creatinine 1.5 mg/dL or creatinine clearance of 60 mL/min based on a 24-hour urine collection", " Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2", " Women of childbearing potential and men must agree to use an effective method of birth control (e.g., hormonal, barrier) while receiving study treatment", "Exclusion Criteria:", " History of significant cardiac disease, unstable angina, CHF, myocardial infarction, or ventricular arrhythmia requiring medication", " History of Grade 3 hypersensitivity reaction to trastuzumab", " History of any toxicity to trastuzumab that resulted in trastuzumab being permanently discontinued", " Symptomatic brain metastases or any radiation or surgery for brain metastases within 3 months of first study treatment", " Require supplemental oxygen for daily activities", " Grade 2 peripheral neuropathy", " Bisphosphonate therapy for symptomatic hypercalcemia", " Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 4 weeks of first study treatment", " Any experimental therapy within 4 weeks of first study treatment", " Any major surgical procedure within 4 weeks of first study treatment", " History of clinically symptomatic liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis", " Pregnancy or lactation", " Cardiac troponin I 0.2 ng/mL", " Ejection fraction < 50% or below the lower limit of normal determined by echocardiogram or MUGA scan", " Prior cumulative doxorubicin dose of > 360 mg/m2 or equivalent" ]

[ "Adverse Events 1:", " Total: 9/29 (31.03%)", " Neutropenia 5/29 (17.24%)", " Cataracts 1/29 (3.45%)", " Abdominal Pain 1/29 (3.45%)", " Perforated Appendix 1/29 (3.45%)", " Surgical Intervention 1/29 (3.45%)", " Deep Vein Thrombosis 1/29 (3.45%)", " Cerebrovascular Ischemia 1/29 (3.45%)", "Adverse Events 2:", " " ]

[ "Adverse Events 1:", " Total: 2/3 (66.67%)", " Febrile neutropenia 1/3 (33.33%)", " Atrial flutter 0/3 (0.00%)", " Atrial fibrillation 0/3 (0.00%)", " Cardiac failure 0/3 (0.00%)", " Sinus bradycardia 1/3 (33.33%)", " Supraventricular tachycardia 0/3 (0.00%)", " Abdominal pain upper 0/3 (0.00%)", " Dysphagia 0/3 (0.00%)", " Intestinal mass 0/3 (0.00%)", " Pancreatitis acute 0/3 (0.00%)", " Small intestinal obstruction 0/3 (0.00%)", "Adverse Events 2:", " Total: 0/3 (0.00%)", " Febrile neutropenia 0/3 (0.00%)", " Atrial flutter 0/3 (0.00%)", " Atrial fibrillation 0/3 (0.00%)", " Cardiac failure 0/3 (0.00%)", " Sinus bradycardia 0/3 (0.00%)", " Supraventricular tachycardia 0/3 (0.00%)", " Abdominal pain upper 0/3 (0.00%)", " Dysphagia 0/3 (0.00%)", " Intestinal mass 0/3 (0.00%)", " Pancreatitis acute 0/3 (0.00%)", " Small intestinal obstruction 0/3 (0.00%)" ]

[ "Outcome Measurement: ", " Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to Month 24", " Bone mineral density (BMD) by DXA at lumbar spine (L2-L4); DXA assessments of the BMD at dual hips. (BMD). Two X-ray beams with different energy levels are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone.", " Time frame: baseline, month 24", "Results 1: ", " Arm/Group Title: Placebo", " Arm/Group Description: Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).", " Overall Number of Participants Analyzed: 36", " Mean (Standard Deviation)", " Unit of Measure: Z-score -0.075 (0.041)", "Results 2: ", " Arm/Group Title: Zometa", " Arm/Group Description: Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).", " Overall Number of Participants Analyzed: 34", " Mean (Standard Deviation)", " Unit of Measure: Z-score 0.037 (0.042)" ]

[ "Outcome Measurement: ", " Progression Free Survival (PFS)", " PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or progression in a non-target lesion, or the appearance of new lesions. The primary analysis of PFS was based on PFS events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria.", " Time frame: Evaluated every 6 - 9 weeks following treatment initiation", "Results 1: ", " Arm/Group Title: Capecitabine", " Arm/Group Description: Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.", " Overall Number of Participants Analyzed: 109", " Median (95% Confidence Interval)", " Unit of Measure: months 2.8 (1.6 to 3.2)", "Results 2: ", " Arm/Group Title: CDX-011", " Arm/Group Description: CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.", " Overall Number of Participants Analyzed: 218", " Median (95% Confidence Interval)", " Unit of Measure: months 2.9 (2.8 to 3.5)" ]

[ "Outcome Measurement: ", " Proportion of Patients With Confirmed Tumor Response", " Confirmed tumor response was defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria on 2 consecutive evaluations at least 8 weeks apart.", " Time frame: Up to 5 years", "Results 1: ", " Arm/Group Title: Treatment (Ziv-afibercept)", " Arm/Group Description: Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 21", " Measure Type: Number", " Unit of Measure: Participants Confirmed tumor partial response: 1", " No Confirmed reponse: 20" ]

[ "Outcome Measurement: ", " Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)", " Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.", " Time frame: Baseline and Week 13", "Results 1: ", " Arm/Group Title: Bisphosphonate IV Q4W", " Arm/Group Description: Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion", " Overall Number of Participants Analyzed: 38", " Mean (Standard Deviation)", " Unit of Measure: Percent change -10.19 (208.84)", "Results 2: ", " Arm/Group Title: Denosumab 30 mg Q4W", " Arm/Group Description: Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)", " Overall Number of Participants Analyzed: 40", " Mean (Standard Deviation)", " Unit of Measure: Percent change -52.87 (95.14)" ]

[ "INTERVENTION 1: ", " Mammography Only", " For this reporting arm, the interpretation and analysis was done with mammography only.", "INTERVENTION 2: ", " Mammography With Adjunct MBI", " For this reporting arm, the interpretation and analysis was done with both mammography and MBI together." ]

[ "INTERVENTION 1: ", " Arm 1 (6 mg Estradiol)", " 6 mg of estradiol daily (2 mg tid).", "INTERVENTION 2: ", " Arm 2 (30 mg Estradiol)", " 30 mg of estradiol. (10 mg tid)" ]

[ "Inclusion Criteria:", " Participants with a confirmed diagnosis of clinical stage 1 or 2 breast cancer", " Participants who are undergoing breast cancer surgery with lumpectomy or mastectomy", " Participants with planned axillary sentinel node biopsy procedure", "Exclusion Criteria:", " Participants with cancer > 3 cm", " Participants with clinically positive nodes", " Participants with prior surgery for breast cancer in the index breast", " Participants who have had bilateral breast surgeries", " Thyroid dysfunction", " Hypersensitivity to iodine", " Hepatic insufficiency", " Renal insufficiency" ]

[ "Inclusion Criteria:", " Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer", " Prior use of Herceptin (trastuzumab), and a taxane", " Adequate cardiac and renal function", "Exclusion Criteria:", " More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]", " Bone as the only site of disease", " Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)", " Significant gastrointestinal disorder with diarrhea as major symptom" ]

[ "Outcome Measurement: ", " Pathologic Assessment After Study Treatment", " Pathologic Assessment After 12 weeks of lapatinib and trastuzumab with or without endocrine therapy. Pathologic complete response: no invasive cancer in the residual breast. Near pathologic complete response: residual disease of less than 1 cm in breast.", " Time frame: 12 weeks", "Results 1: ", " Arm/Group Title: Lapatinib + Trastuzumab", " Arm/Group Description: All study participants received lapatinib 1000mg daily and trauzumab 4mg/kg loading dose and then 2mg/kg every week", " Overall Number of Participants Analyzed: 64", " Measure Type: Number", " Unit of Measure: participants Complete Pathologic Response: 18", " Near Complete Pathologic Response: 16", " Not Pathologic response: 30" ]

[ "INTERVENTION 1: ", " Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2", " Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.", "INTERVENTION 2: ", " Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2", " Cohort 2: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 140mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days." ]

[ "Inclusion Criteria:", " Patient is an adult, 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines", " Women and men with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.", " Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive and HER2-negative breast cancer by local laboratory. Local pathology is sufficient for assessment.", " Patient must have either:", " Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria ).", " Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease", " Non-measurable disease", " Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 2", " Exclusion Criteria", " Patient who received any CDK4/6 inhibitor or any mTOR inhibitor.", " Patient has a known hypersensitivity to any of the excipients of ribociclib or letrozole", " Patients with current inflammatory breast cancer.", " Patient has received > 1 chemotherapy for the treatment of advanced/metastatic breast cancer", " Patient has received > 2 endocrine therapies for the treatment of advanced/metastatic breast cancer", " Patient has central nervous system (CNS) involvement. If patient is fulfilling the following 3 criteria she/he is eligible for the trial.", " completed prior therapy (including radiation and/or surgery) for CNS metastases 28 days prior to the start of study and", " CNS tumor is clinically stable at the time of screening and", " Patient is not receiving steroids and enzyme inducing anti-epileptic medications for brain metastases", " Patient has active cardiac disease or a history of cardiac dysfunction" ]

[ "Inclusion Criteria:", " Stage 1-2 invasive breast cancer diagnosis,", " DCIS", " Ability to read English", "Exclusion Criteria:", "Male" ]

[ "INTERVENTION 1: ", " Arm A: Endocrine Therapy (ET)", " Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.", " Letrozole", "Fulvestrant", "INTERVENTION 2: ", " Arm B: ET With Bevacizumab (ET-B)", " Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg i.v. on day 1 every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.", " Letrozole", " Bevacizumab", "Fulvestrant" ]

[ "The following information on clinical trials is provided for information purposes only to allow participants and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.", "INCLUSION CRITERIA:", " Histologically or cytologically proven adenocarcinoma of the breast at first diagnosis", " Stage IV disease with at least one measurable lesion according to the RECIST criteria", " HER2/neu positive as determined by 3+ immunohistochemistry (IHC) staining or fluorescence in situ hybridization (FISH) positivity or negative tumors", " Life expectancy of >/= 24 weeks", " No prior chemotherapy for metastatic breast cancer. (Prior endocrine therapy is permitted).", " Prior neoadjuvant or adjuvant chemotherapy is permitted, or at least 12 months must have elapsed since the neoadjuvant or adjuvant therapy. Subjects may have received prior adjuvant anthracyclines (maximum cumulative dose, 360 mg/m^2 doxorubicin or 750 mg/m^2 epirubicin)", " At least 4 weeks since prior surgery, radiotherapy, endocrine therapy, or experimental drug therapy with complete recovery from the effects of these interventions", " It is recommended that all baseline staging should be completed within 35 days prior to study entry. All subjects will have the following workup as applicable; CT scan of brain, CT scan or MRI of chest and abdomen, and bone scan or PET scan. In cases of positive bone or PET scans, bone X-ray evaluation and/or MRI is required to confirm or exclude metastatic bone disease. Subjects with metastatic disease limited to bone are ineligible unless at least one lytic lesion is measurable and can be followed by RECIST criteria. Other tests may be performed as clinically indicated", " Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) of >/= 50% or shortening fraction (multiple-gated acquisition [MUGA] scan or echocardiography respectively). The result must be greater than the lower limit of normal (LLN) for the institution.", " Subjects receiving bisphosphonate therapy; however, if bisphosphonates were started within <2 months prior to treatment the bone lesions will not be evaluated for response, and the subjects must have another site of metastatic disease that is either measurable or evaluable for response", "EXCLUSION CRITERIA:", " Prior chemotherapy for metastatic breast cancer", " Prior treatment with bevacizumab or other anti-VEGF therapy", " Concurrent treatment with any other non-protocol anticancer therapy with the exception of radiation therapy as long as all target lesions being followed are not in the radiation field and if HER2/neu positive, HER2/neu-directed therapy", " Current or prior history of brain or leptomeningeal metastases", " Presence of neuropathy >/= 2", " Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically significant (>/= Grade 2) peripheral vascular disease", " History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma in-situ of the cervix", " Clinically significant cardiovascular disease", " Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning therapy", " History of bleeding diathesis or coagulopathy" ]

[ "INTERVENTION 1: ", " AeroForm Tissue Expander", " AeroForm Tissue Expansion inflation with carbon dioxide by remote control", " AeroForm Tissue Expander: The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander." ]

[ "INTERVENTION 1: ", " IUS Alone", "IUS alone imaging", "INTERVENTION 2: ", " Imagio (IUS+OA)", "IUS+OA imaging" ]

[ "Adverse Events 1:", " Total: 31/52 (59.62%)", " Febrile neutropenia 2/52 (3.85%)", " Left ventricular dysfunction 2/52 (3.85%)", " Sinus tachycardia 1/52 (1.92%)", " Congenital arterial malformation 1/52 (1.92%)", " Diarrhoea 5/52 (9.62%)", " Salivary hypersecretion 1/52 (1.92%)", " Enteritis 1/52 (1.92%)", " Abdominal pain 1/52 (1.92%)", " Vomiting 1/52 (1.92%)", " Stomatitis 1/52 (1.92%)", " Haematemesis 1/52 (1.92%)" ]

[ "Adverse Events 1:", " Total: 57/57 (100.00%)", " Dry eyes 13/33 (39.39%)", " Heartburn 9/33 (27.27%)", " Nausea after the CT (before day 7) 57/57 (100.00%)", " Herpetic eruption 0/33 (0.00%)", " Dry skin 15/33 (45.45%)", " Alopecia 57/57 (100.00%)", "Adverse Events 2:", " Total: 23/23 (100.00%)", " Dry eyes 2/11 (18.18%)", " Heartburn 2/11 (18.18%)", " Nausea after the CT (before day 7) 23/23 (100.00%)", " Herpetic eruption 3/11 (27.27%)", " Dry skin 9/11 (81.82%)", " Alopecia 23/23 (100.00%)" ]

[ "Inclusion Criteria:", " Patients must have histologically or cytologically confirmed primary invasive breast cancer", " Primary tumor is larger than 2 cm in diameter (T2) as measured by caliper or ultrasound", " Overexpression and/or amplification of HER2 is confirmed by immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) + when IHC 2+", " Patients have not received prior therapies for breast cancer", " Patients have Karnofsky >= 70%", " Leukocytes >= 3,000/mcL", " Absolute neutrophil count >= 1,500/mcL", " Hemoglobin >= 9.0 g/dL", " Platelets >= 75,000/mcL", " Total bilirubin =< 1.5 times institutional upper limit of normal", " Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase[SGPT]) =< 2.5 times institutional ULN", " Creatinine =< 1.5 times institutional upper limit of normal (ULN)", " Patients must have left ventricular ejection fraction (LVEF) >= 50% by multi-gated acquisition (MUGA) or echocardiography", " Patients must be able to take oral medications (i.e., no uncontrolled vomiting, inability to swallow, or diagnosis of chronic malabsorption)", " Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation as well as for at least 6 months after the last dose of trastuzumab", " Ability to understand and willingness not only for treatment but also for undergoing serial biopsies and sign a written informed consent document", " Only Japanese women are eligible for the trial", "Exclusion Criteria:", " Patients who have had chemotherapy or radiotherapy", " Patients who are receiving any other investigational agents", " Patients have distal metastasis (stage IV disease)", " Patients with previous (within 10 years) or current history of malignant neoplasm except for curatively treated basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix", " Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or other agents used in study", " Patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) are ineligible", " Patients who have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements", " Pregnant women", " Patients who have family or personal history of congenital long or short QT syndrome, Brugada syndrome, QT/QTc prolongation, or torsade de pointes", " Patients who have chronic gastrointestinal disease presenting with diarrhea (inflammatory bowel disease, malabsorption, or >= grade 2 diarrhea of any etiology at baseline)", " Patients who have neuropathy >= grade 2 of any cause", " Patients are diagnosed with inflammatory breast cancer or bilateral breast cancer" ]

[ "INTERVENTION 1: ", " Afatinib 50 mg", " Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.", "INTERVENTION 2: ", " Lapatinib 1500 mg", " Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial." ]

[ "Outcome Measurement: ", " Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)", " Percentage of patients with AEs.", " Time frame: Adverse events were collected from treatment initiation to end of the study about 6 months for each patient.", "Results 1: ", " Arm/Group Title: Single Arm", " Arm/Group Description: fulvestrant (Faslodex )", " Overall Number of Participants Analyzed: 81", " Measure Type: Number", " Unit of Measure: Percentage of participants Adverse Events(AE): 81.5 (71.3 to 89.3)", " ADR; based on current South Korea label.: 38.3 (27.7 to 49.7)", " Serious AE: 11.1 (5.2 to 20.1)", " Serious ADR: 0 (0 to 4.4)", " Unexpected AE: 71.6 (60.5 to 81.1)", " Unexpected ADR: 24.7 (15.8 to 35.5)" ]

[ "Inclusion Criteria:", " - Female 18 years, 70 years. ECOG 0-1 with no deterioration over previous 2 weeks Minimum life expectancy 3 months Histological confirmation of hormone receptor-high expressed breast cancer(IHC:ER 60% and PR 60%) on primary tumour at diagnosis/on biopsy of metastasis Histological confirmation of HER2 negative breast cancer on primary tumour at diagnosis/on biopsy of a metastasis The disease-free time of relapsed patients is more than 12 months Once received standard hormone treatment and progressed Clinical or histological confirmation of metastatic or locally advanced disease not amenable to curative surgical resection At least one evaluative focus according to RECIST creterion or non-measurable disease but only bone metastasis Adequate bone marrow and organ function Progressive disease whilst receiving endocrine therapy for locally advanced or metastatic BC or relapsed with metastatic disease whilst receiving endocrine therapy Radiological or objective clinical evidence of recurrence or progression on or after last systemic therapy prior to enrolment", " 4 prior lines of endocrine therapy for ABC", " 3 line of cytotoxic chemotherapy for ABC Suitable for further endocrine therapy Availability of archival tumour sample or fresh biopsy Informed consent Normal organ function", "Exclusion Criteria:", " Last dose chemotherapy, immunotherapy targeted therapy, biological therapy or tumour embolisation <21 days prior to study treatment Last dose of palliative radiotherapy <7 days prior to study treatment Rapidly progressive visceral disease not suitable for further endocrine therapy Spinal cord compression or brain/meningeal metastases unless asymptomatic, treated and stable and not requiring steroids for 4 weeks study treatment Creatinine clearance <30 ml/min. Patients with creatinine clearance <50 mL/min will start at a permanently reduced vandetanib dose of 200 mg.", " Major surgery (excluding placement of vascular access) within 4 weeks before study treatment Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment Elevated ALP in absence of bone metastasis Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent Participation in another study with investigational product during last 30 days Inability or unwillingness to comply with study procedures, including inability to take regular oral medication" ]

[ "Adverse Events 1:", " Total: 14/76 (18.42%)", " Neutropenia 10/76 (13.16%)", " Febrile neutropenia 1/76 (1.32%)", " Anaemia 0/76 (0.00%)", " Thrombocytopenia 0/76 (0.00%)", " Cardiopulmonary failure 0/76 (0.00%)", " Optic ischaemic neuropathy 0/76 (0.00%)", " Bowel peristalsis increased 1/76 (1.32%)", " Colitis 0/76 (0.00%)", " Diarrhoea 0/76 (0.00%)", " Gastritis 0/76 (0.00%)", " Nausea 0/76 (0.00%)", "Adverse Events 2:", " Total: 12/76 (15.79%)", " Neutropenia 2/76 (2.63%)", " Febrile neutropenia 1/76 (1.32%)", " Anaemia 0/76 (0.00%)", " Thrombocytopenia 0/76 (0.00%)", " Cardiopulmonary failure 1/76 (1.32%)", " Optic ischaemic neuropathy 1/76 (1.32%)", " Bowel peristalsis increased 0/76 (0.00%)", " Colitis 1/76 (1.32%)", " Diarrhoea 0/76 (0.00%)", " Gastritis 0/76 (0.00%)", " Nausea 1/76 (1.32%)" ]

[ "Inclusion Criteria:", " The patient is capable to understand and comply with the protocol and has signed the informed consent document.", " Females with histologically confirmed advanced breast cancer.", " TN breast cancer by local laboratory determination. Hormonal Receptor (HR) negative defined as < 1% positive cells by Immunohistochemistry (IHC) for both Estrogen Receptor (ER) and Progesterone Receptor (PgR), and HER2 negative defined as in situ hybridization (ISH) negative or IHC 0 or 1+ in the absence of ISH (Note: patients with IHC 2+ must have an ISH determination in order to confirm the HER2 negativity.", " Measurable or non-measurable disease according to RECIST 1.1 criteria.", " Patient is at least 18 years of age.", " World Health Organization (WHO) Performance Status 1.", " Life expectancy 12 weeks.", " Common laboratory values within normal range (…)", " A negative serum pregnancy test 72 hours before starting study treatment for pre-menopausal women and for women < 1 year from the last menstruation date.", "Exclusion Criteria:", " Have received more than 3 prior chemotherapy regimens for ABC.", " Patients with untreated brain metastases. However, a patient with Central Nervous System (CNS) metastases may participate in this trial if > 4 weeks from therapy completion (incl. radiation and/or surgery), is clinically stable with respect to the tumor at the time of study entry and is not receiving corticosteroid therapy.", " Patients with acute or chronic liver or renal disease or pancreatitis.", " Patients with a second primary malignancy that is clinically detectable at the time of consideration for study enrollment.", " Patients unable to swallow tablets.", " History of a positive HIV test (HIV testing is not mandatory).", " History of a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result (Hepatitis B or C testing is not mandatory).", " Impairment of gastrointestinal (GI) function or GI disease (e.g. ulcerative disease, uncontrolled nausea, vomiting, grade 2 diarrhea, malabsorption syndrome or small bowel resection).", " Peripheral vascular disease requiring active therapy or having had surgery < 12 months prior to starting study drug.", " Impaired cardiac function or clinically significant heart disease (…)", " A past medical history of clinically significant ECG abnormalities or a family history of prolonged QT-interval syndrome", " Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)", " Patients who are receiving treatment with medications that are known to be strong inhibitors or inducers of CYP3A4/5 (listed in Protocol Attachment 3) or drugs metabolized by CYP2B6 or CYP2C9 (listed in Protocol Attachment 3) that cannot be discontinued prior to study entry and for the duration of the study. Medications that are strong CYP3A4/5 inhibitors should be discontinued for at least 2 days, and strong CYP3A4/5 inducers for at least 1 week prior to initiating LDE225 dosing.", " Patients who have received chemotherapy within a period of time that is < the cycle length used for that treatment (e.g. < 3 weeks for fluorouracil, doxorubicine, epirubicin) prior to starting study drug or who have not recovered from the side effects of such therapy.", " Patients who have received biologic therapy (e.g. antibodies) 4 weeks prior to starting study drug or who have not recovered from the side effects of such therapy.", " Patients who have been treated with a small molecule therapeutic 5 t1/2 or 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy.", " Patients who have received any other investigational agents 5 t1/2 or 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy.", " Patients who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) 4 weeks or limited field radiation for palliation 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.", " Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin) who cannot discontinue this treatment at least 5 days prior to starting study drug.", " Patients who are currently receiving immunosuppressive treatment and in whom the treatment cannot be discontinued prior to starting study drug, except in the case of patients with basal cell carcinoma (BCC). Immunosuppressive treatment should be discontinued for at least 1 week prior to initiating LDE225 dosing.", "…" ]

[ "Outcome Measurement: ", " Phase 1 - Maximum Tolerated Dose (MTD) in Milligrams (mg)", " MTD of 1-methyl-d-tryptophan (indoximod) given by mouth (PO), twice a day (BID), with up to 6 fixed doses Ad.p53 DC vaccinations every 2 weeks (q2wks). This phase 1 study used a 3+3 design with 7 indoximod dose levels (DL) (100 mg, 200 mg, 400 mg, 800 mg daily (QD) then 800 mg, 1,200 mg, and 1,600 mg PO BID +up to 6 fixed dose Ad.p53 DC vaccinations q2wks. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. The MTD is the highest dose level below the maximally administered dose (MAD) that is safely tolerated among 6 treated patients, that is, 0 or 1 out of 6 patients experiences a dose limiting toxicity (DLT).", " Time frame: Up to 4 weeks", "Results 1: ", " Arm/Group Title: Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)", " Arm/Group Description: Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.", " adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)", " 1-methyl-d-tryptophan: Given orally (PO)", " Laboratory biomarker analysis: Correlative studies", " Overall Number of Participants Analyzed: 30", " Measure Type: Number", " Unit of Measure: indoximod dose in mg 1600" ]

[ "INTERVENTION 1: ", " Part 1: Dose Escalation: Cohort 1", " MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV", "INTERVENTION 2: ", " Part 1: Dose Escalation: Cohort 2", " MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV", " Paclitaxel - 80mg/m2 weekly IV" ]

[ "Inclusion Criteria", " Histologically-confirmed HER2-positive (IHC 3+ or fluorescence in situ hybridization (FISH) amplified; by clinical assay on either primary or metastatic tumor) adenocarcinoma of the breast with at least one progressive and/or new metastatic brain lesion (>/=5 mm on radiographic imaging) after receipt of intracranial radiation therapy (whole brain radiation therapy, stereotactic radiosurgery, gamma knife, or equivalent). Patients in whom brain metastases (BM) are asymptomatic and detected during routine brain MRI screening per institutional protocols are eligible.", " Prior intracranial radiation therapy (whole brain radiation therapy, stereotactic radiosurgery, gamma knife or equivalent) is allowed but not required.", " Patients with no prior treatment with intracranial Response (ICR) may be included unless ICR is emergently indicated (in consultation with a local therapist, ie neurosurgeon or radiation oncologist)", " Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.", " Life expectancy >12 weeks.", " At least 21 years of age.", " No prior mTOR inhibitors", " Prior navelbine allowed provided navelbine therapy discontinued >/= 12 months from Day 1 of treatment under this protocol.", " Last anti-cancer treatment (including any investigational drug) >/= 2 weeks from initiation of protocol based therapy, provided all adverse events (AEs) (other than alopecia) have resolved to grade 1 at baseline.", " No active serious infection or other comorbid illness which would impair ability to participate in the trial.", " Left ventricular ejection fraction assessment (echocardiogram or multigated acquisition scan (MUGA) scan) performed within 4 weeks prior to study initiation, showing a Left ventricular ejection fraction (LVEF) value lower limit of normal (LLN).", " If patient is on dexamethasone, must be on stable or decreasing dose of dexamethasone for 7 days. If patient is on different glucocorticoid e.g., prednisone, must be converted to dexamethasone prior to enrollment. Refer to dose modification of everolimus for patients taking dexamethasone.", " Interval 4 weeks between open brain biopsy and initiation of protocol-based therapy.", " international normalized ratio (INR) 2.0. Anticoagulation is allowed if target INR 2.0 on a stable dose of warfarin or if patient on a stable dose of Low-molecular-weight (LMW) heparin for >1 weeks at time of enrollment.", " Fasting serum cholesterol 300 mg/dL OR 7.75 mmol/L AND fasting triglycerides 2.5 x ULN. Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.", " Patients must have adequate organ function as evidenced by:", " Absolute neutrophil count 1.5/µL", " Platelet count 100,000/µL", " Hg 9 g/dL", " Bilirubin 1.5 x upper limit of normal (ULN)", " aspartate aminotransferase (AST) or Alanine transaminase (ALT) 2.5 x ULN ( 5 x ULN if liver metastases are present)", " Serum creatinine 1.5 x ULN", " Archived, paraffin-embedded tissue block (primary or metastatic) available for genomic studies is required.", " Signed, institutional review board (IRB)-approved written informed consent.", " Exclusion Criteria", " Patients who have received prior treatment with an mTOR inhibitor (e.g., sirolimus, temsirolimus, everolimus); patients who have received prior treatment with navelbine within prior 12 months.", " patients with a known hypersensitivity to everolimus or other rapamycins (e.g. sirolimus, temsirolimus) or to its excipients.", " Patients requiring treatment with any other systemic glucocorticoid. Note: This restriction regarding choice of glucocorticoid does not apply should patient need <2 week course of glucocorticoid for treatment of non-infectious pneumonitis during study (see section 4.5.2).", " Patients with a known hypersensitivity to vinorelbine or to its excipients.", " Prior allergic reaction to trastuzumab for the treatment of metastatic breast cancer.", " Concurrent or planned radiation, hormonal, chemotherapeutic, experimental or targeted biologic therapy.", " Peripheral neuropathy grade 3.", " Evidence of frank hemorrhage or impending herniation on baseline brain imaging. Note: asymptomatic micro-hemorrhage is allowed.", " Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented Cerebrospinal fluid (CSF) cytology. Note: discrete dural metastases are permitted.", " Active cardiac disease including any of the following:", " Angina pectoris that requires the use of anti-anginal medication;", " Ventricular arrhythmias except for benign premature ventricular contractions;", " Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;", " Conduction abnormality requiring a pacemaker;", " Valvular disease with documented compromise in cardiac function;", " Symptomatic pericarditis", " History of cardiac dysfunction including any one of the following:", " Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;", " History of documented congestive heart failure (New York Heart Association functional classification III-IV);", " Documented cardiomyopathy", " Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia), or patients that may require major surgery during the course of the study.", " Patients should not receive immunization with attenuated live vaccines within 1 week of study entry or during study period. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guérin (BCG), yellow fever, varicella, and Typhoid Vaccine Live Oral (TY21a) typhoid vaccines.", " Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.", " Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:", " severely impaired lung function, defined as spirometry and diffusion lung capacity for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or 02 saturation that is 88% at rest on room air", " uncontrolled diabetes, defined as fasting serum glucose >1.5 x ULN (Note: Optimal glycemic control should be achieved before starting trial therapy)", " active (acute or chronic) or uncontrolled severe infections", " liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).", " Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. Hepatitis B Virus (HBV) DNA and hepatitis C Virus (HCV) RNA polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.", " A known history of HIV seropositivity.", " Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).", " Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low-dose warfarin and aspirin or equivalent, as long as the INR 2.0).", " Unable or unwilling to discontinue use of prohibited fruit (or its juices) and prohibited medications listed in Appendices II and III for at least 14 days or 5 half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.", " Female patients who are pregnant or breastfeeding, or adults of reproductive potential who are not using effective birth control methods. Adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 7 days prior to everolimus initiation.", " Male patients whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment", " Contraindication to gadolinium-enhanced MRI imaging.", " Inability to comply with study and/or follow-up procedures.", " History of noncompliance to medical regimens." ]

[ "Adverse Events 1:", " Total: 67/349 (19.20%)", " Anaemia * 3/349 (0.86%)", " Leukopenia * 1/349 (0.29%)", " Neutropenia * 3/349 (0.86%)", " Thrombocytopenia * 1/349 (0.29%)", " Atrial fibrillation * 2/349 (0.57%)", " Cardiac arrest * 1/349 (0.29%)", " Cardiac failure * 0/349 (0.00%)", " Cardiac failure acute * 0/349 (0.00%)", " Cardio-respiratory arrest * 2/349 (0.57%)", " Cardiovascular insufficiency * 0/349 (0.00%)", "Adverse Events 2:", " Total: 69/353 (19.55%)", " Anaemia * 2/353 (0.57%)", " Leukopenia * 1/353 (0.28%)", " Neutropenia * 1/353 (0.28%)", " Thrombocytopenia * 1/353 (0.28%)", " Atrial fibrillation * 0/353 (0.00%)", " Cardiac arrest * 1/353 (0.28%)", " Cardiac failure * 4/353 (1.13%)", " Cardiac failure acute * 1/353 (0.28%)", " Cardio-respiratory arrest * 0/353 (0.00%)", " Cardiovascular insufficiency * 1/353 (0.28%)" ]

[ "Inclusion Criteria:", " Prospectively confirmed HER2-positive (i.e., IHC 3+ or IHC 2+ and gene amplified by fluorescence in situ hybridization [FISH] positive) as assessed on primary tumor and/or metastatic site", " Documented progression of unresectable, locally advanced, or mBC, determined by the investigator", " Left ventricular ejection fraction (LVEF) >/= 50% by echocardiogram (ECHO)", " Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1", " A negative serum Beta-Human Chorionic Gonadotropin (Beta-HCG) test for women of childbearing potential (premenopausal or not meeting the definition of postmenopausal i.e. >/= 12 months of amenorrhea), and women who have not undergone surgical sterilization (i.e., absence of ovaries and/or uterus)", " For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate non-hormonal methods of contraception, including at least one method with a failure rate of <1% per year, during the treatment period and for at least 7 months after the last dose of study drug", " For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm. With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 7 months plus 90 days (a spermatogenesis cycle) after the last dose of study drug. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 7 months after the last dose of study drug.", "Exclusion Criteria:", " Prior treatment with trastuzumab emtansine", " Prior treatment with lapatinib or lapatinib with capecitabine or non-comparable biologic or biosimilar of trastuzumab", " Peripheral neuropathy of Grade >/= 3 per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE [version 4.03])", " History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar curative outcome as those mentioned above", " History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to enrollment except hormone therapy, which can be given up to 7 days prior to enrollment; recovery of treatment-related toxicity consistent with other eligibility criteria", " History of exposure to cumulative doses of anthracyclines, as defined in the protocol", " History of radiation therapy within 14 days of enrollment", " Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as a history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) before enrollment", " CNS only disease", " History of a decrease in LVEF to < 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment", " History of symptomatic chronic heart failure (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment", " History of myocardial infarction or unstable angina within 6 months of enrollment", " Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy", " Current severe, uncontrolled systemic disease", " Pregnancy or lactation", " Concurrent, serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV) or active hepatitis B and/or hepatitis C. For patients who are known carriers of hepatitis B virus (HBV), active hepatitis B infection must be ruled out, based on negative serologic testing and/or determination of HBV DNA viral load per local guidelines", " Presence of conditions that could affect gastrointestinal absorption: malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis", " History of intolerance (such as Grade 3-4 infusion reaction) or known hypersensitivity to trastuzumab or murine proteins or any component of the product", " Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol" ]

[ "Inclusion Criteria:", " Female gender;", " Age 18 years;", " Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1", " Histologically confirmed invasive breast cancer:", " Primary tumor greater than 1 cm diameter, measured by clinical examination and mammography or ultrasound.", " Any N,", " No evidence of metastasis (M0) (isolated supra-clavicular node involvement allowed);", " Over expression and/or amplification of HER2 in the invasive component of the primary tumor and confirmed by a certified laboratory prior to randomization.", " Known hormone receptor status.", " Hematopoietic status:", " CBC not less than .75 of institutional lower limit. Absolute neutrophil count 1,5 x 10^9/L, Platelet count 100 x 10^9/L, Hemoglobin at least 9 g/dl,", " Hepatic status:", " Serum total bilirubin 2 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (< 1.5 x ULN) is allowed, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 3.5 times ULN, Alkaline phosphatase 2.5 times ULN, Renal status: Creatinine 1.5mg/dL,", " Cardiovascular: Baseline left ventricular ejection fraction (LVEF) ³ 50% measured by echocardiography (ECHO) or Multiple Gate Acquisition (MUGA) scan,", " Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential within 2-weeks (preferably 7 days) prior to randomization.", " Fertile patients must use effective contraception (barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed)", " Signed informed consent form (ICF)", " Patient accepts to make available tumor samples for submission to central laboratory to conduct translational studies as part of this protocol.", "Exclusion Criteria:", " Previous (less than 5 years) or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin; Carcinoma in situ of the cervix.", " Patients with a prior malignancy diagnosed more than 5 years prior to randomization may enter the study.", " Preexisting peripheral neuropathy grade 2", " Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ( 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen;", " Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety;", " Unresolved or unstable, serious adverse events from prior administration of another investigational drug;", " Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;", " Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;", " Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies);", " Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;", " Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab Emtansine, trastuzumab, lapatinib, paclitaxel, abraxane or their components;", " Pregnant or lactating women;", " Concomitant use of CYP3A4 inhibitors or inducers", " Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol", " Patients have an active infection and require IV or oral antibiotics.", " Pregnant or breast-feeding women", " Patients unwilling or unable to comply with the protocol" ]

[ "INTERVENTION 1: ", " Treatment (Tivantinib)", " Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.", " Laboratory Biomarker Analysis: Correlative studies", " Tivantinib: Given PO" ]

[ "INTERVENTION 1: ", " Prone", "Prone position", "INTERVENTION 2: ", " Supine", "Supine position" ]

[ "Outcome Measurement: ", " Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS)", " The study team will assess the percent of participants without CNS progression at 3 months. The study team will generate a Kaplan- Meier curve of CNS PFS and estimate the PFS and 95% confidence interval (CI) of the PFS. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.", " Time frame: At 12 weeks", "Results 1: ", " Arm/Group Title: Eribulin Mesylate", " Arm/Group Description: The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate", " Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.", " MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate", " Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician", " Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician", " Overall Number of Participants Analyzed: 9", " Measure Type: Number", " Unit of Measure: percentage of participants 88.9 (51 to 99.7)" ]

[ "Adverse Events 1:", " Total: 58/305 (19.02%)", " FEBRILE NEUTROPENIA * 12/305 (3.93%)", " NEUTROPENIA * 4/305 (1.31%)", " ANAEMIA * 2/305 (0.66%)", " LEUKOPENIA * 1/305 (0.33%)", " PANCYTOPENIA * 1/305 (0.33%)", " THROMBOCYTOPENIA * 1/305 (0.33%)", " DISSEMINATED INTRAVASCULAR COAGULATION * 0/305 (0.00%)", " ATRIAL FIBRILLATION * 1/305 (0.33%)", " DIASTOLIC DYSFUNCTION * 1/305 (0.33%)", " PERICARDIAL EFFUSION * 1/305 (0.33%)", "Adverse Events 2:", " Total: 50/304 (16.45%)", " FEBRILE NEUTROPENIA * 12/304 (3.95%)", " NEUTROPENIA * 1/304 (0.33%)", " ANAEMIA * 0/304 (0.00%)", " LEUKOPENIA * 0/304 (0.00%)", " PANCYTOPENIA * 0/304 (0.00%)", " THROMBOCYTOPENIA * 0/304 (0.00%)", " DISSEMINATED INTRAVASCULAR COAGULATION * 1/304 (0.33%)", " ATRIAL FIBRILLATION * 1/304 (0.33%)", " DIASTOLIC DYSFUNCTION * 0/304 (0.00%)", " PERICARDIAL EFFUSION * 0/304 (0.00%)" ]

[ "Adverse Events 1:", " Total: 31/52 (59.62%)", " Febrile neutropenia 2/52 (3.85%)", " Left ventricular dysfunction 2/52 (3.85%)", " Sinus tachycardia 1/52 (1.92%)", " Congenital arterial malformation 1/52 (1.92%)", " Diarrhoea 5/52 (9.62%)", " Salivary hypersecretion 1/52 (1.92%)", " Enteritis 1/52 (1.92%)", " Abdominal pain 1/52 (1.92%)", " Vomiting 1/52 (1.92%)", " Stomatitis 1/52 (1.92%)", " Haematemesis 1/52 (1.92%)" ]

[ "Adverse Events 1:", " Total: 34/214 (15.89%)", " Leukocytosis 0/214 (0.00%)", " Atrial fibrillation 0/214 (0.00%)", " Cardiac failure congestive 0/214 (0.00%)", " Pericardial effusion 1/214 (0.47%)", " Cataract 0/214 (0.00%)", " Macular fibrosis 0/214 (0.00%)", " Constipation 2/214 (0.93%)", " Diarrhoea 2/214 (0.93%)", " Enterocolitis 0/214 (0.00%)", " Ileus 1/214 (0.47%)", " Nausea 3/214 (1.40%)", "Adverse Events 2:", " Total: 27/213 (12.68%)", " Leukocytosis 1/213 (0.47%)", " Atrial fibrillation 1/213 (0.47%)", " Cardiac failure congestive 1/213 (0.47%)", " Pericardial effusion 0/213 (0.00%)", " Cataract 1/213 (0.47%)", " Macular fibrosis 1/213 (0.47%)", " Constipation 1/213 (0.47%)", " Diarrhoea 1/213 (0.47%)", " Enterocolitis 1/213 (0.47%)", " Ileus 0/213 (0.00%)", " Nausea 0/213 (0.00%)" ]