Statement: the secondary trial uses Clinical Benefit (CBR) as outcome measurement, which is different from Proportion of Participants With a Pathologic Complete Response Rate which is used for the primary trial.
Primary_evidence: 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)
Secondary_evidence: 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