Statement: procedure agents link group identifier is a sequence of characters used to link multiple procedure agents records to a single finding. Women currently undergoing endocrine therapy are excluded from the secondary trial and the primary trial.
Primary_evidence: Inclusion Criteria:   No known soy intolerance   At increased risk of developing breast cancer in >= 1 previously unaffected breast, as defined by any of the following:   Estimated 5-year risk of developing breast cancer using the Gail model, as defined by 1 of the following:   Gail score >= 1.66%   Gail score >= 0.1% for women age 20-29 years   Gail score >= 1.0% for women age 30-39 years   Estimated 5-year risk of developing breast cancer using the Claus model:   Claus score >= 1.66%   Claus score >= 0.1% for women age 20-29 years   Claus score >= 1.0% for women age 30-39 years   Prior diagnosis of unilateral in situ or invasive breast cancer OR history of atypical hyperplasia, BRCA 1 and/or BRCA 2 positivity   History of lobular carcinoma in situ   No evidence of breast cancer, as determined by a negative mammogram within the past 6 months and a history and physical   No previously diagnosed breast cancer unless all systemic therapy (including endocrine therapy) was completed at least 1 year ago   Pre- or postmenopausal   ECOG performance status 0-1   Hemoglobin > 10.0 g/dL   Platelet count > 100,000/mm^3   Absolute neutrophil count > 1,000/mm^3   Creatinine < 2.0 mg/dL   SGPT < 82 U/L   SGOT < 68 U/L   Bilirubin < 3 mg/dL* [Note: * Patients with a higher level of bilirubin due to a familial metabolism may be eligible at the discretion of the investigator]   Life expectancy > 2 years   Not pregnant or nursing   Negative pregnancy test   Fertile patients must use effective barrier contraception   Must be willing to keep a dietary diary   No venous thrombosis within the past year   No unrecognized or poorly controlled thyroid disease   No other cancer within the past 5 years except nonmelanomatous skin cancer or noninvasive cervical cancer   No other medical condition that, in the opinion of the investigator, would jeopardize either the patient or the integrity of the data obtained   None of the following for >= 2 weeks before the first random fine needle aspiration and during study participation:   Oral contraceptives   Soy supplements   High soy-containing foods   Fish oil supplements   Multivitamins   Vitamins C and E   Daily aspirin or nonsteroidal   Anti-inflammatory drugs   No other concurrent investigational agents   No concurrent warfarin or other blood thinners   Female patient Exclusion Criteria:   Women previously diagnosed with breast cancer will not be eligible unless all systemic therapy (including endocrine therapy) was completed at least one year previously   Currently pregnant, or planning to become pregnant during the study period   History of venous thrombosis within past year   Medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained   History of other cancer within the past five years, excluding non-melanomatous skin cancer, and non-invasive cervical cancer   Known soy intolerance   Unrecognized or uncontrolled thyroid disease, subjects may be on synthroid, but thyroid function must be in normal range or the patient's physician must document that the patient's thyroid is controlled.   Currently receiving any other investigational agents   Currently on coumadin, or other blood thinners   History of breast augmentation implants.   Rusults from patients who have <4000 epithelial cells in either the first or the second random Fine-needle aspiration (rFNA) will not be included in the study.
Secondary_evidence: Inclusion Criteria:   Female aged  18 years.   Patients with pathologically documented metastatic triple negative breast cancer (TNBC), eligible for treatment with paclitaxel. Paraffin-embedded tissue must be available from metastatic sites, if reasonably accessible, or from the primary tumor, to confirm the diagnosis of TNBC and for correlative studies (only on metastatic tissue). Fifteen slides can be obtained if the full block is not available to be sent or released.   TNBC will be defined as breast cancer with <1% ER+ and <1% PgR+ cells, and HER2 immunohistochemistry score of 0 or 1+ and/or in situ hybridization (ISH) with HER2 gene copy number <4 or a ratio of less than 2 between HER2 gene copy number and centromere of chromosome 17. Patients whose metastatic disease is TNBC are eligible even when their primary tumor expressed hormone receptors and/or HER2.   Patients must be newly diagnosed metastatic or must have relapsed following a prior (neo)adjuvant chemotherapy regimen. If a taxane (i.e., paclitaxel or docetaxel) was administered as part of the (neo)adjuvant regimen, PD must have occurred > 12 months from the end of previous (neo)adjuvant treatment. For non-taxane (neo)adjuvant regimen, PD must have occurred > 6 months from the end of previous (neo)adjuvant treatment   Patients with at least one baseline measurable lesion according to RECIST criteria version 1.1.   Zubrod (Eastern Co-operative Oncology Group [ECOG]) Performance Status (PS) of 0-1.   Life expectancy of at least three months.   Patients must be able to swallow and retain oral medication (intact tablet).   Able to undergo all screening assessments outlined in the protocol.   Adequate organ function (defined by the following parameters):   Serum creatinine < 140 μmol/L (< 1.6 mg/dL) or creatinine clearance > 60 mL/min.   Serum hemoglobin  9 g/dL; absolute neutrophil count  1.5 x 109/L; platelets  100 x 109/L.   Serum bilirubin  1.5 x upper normal limit (UNL) except patients with Gilbert's syndrome   Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST)  2.5 x UNL but  5.0 x UNL in case of liver metastases; alkaline phosphatase (ALP)  UNL but i)  2.5 x UNL in case of liver metastases and ii)  5 UNL in case of bone metastases; albumin  2.5 g/dl.   No history or evidence by CT scan or MRI, of brain metastases or leptomeningeal disease.   No known hepatitis B virus (not due to immunization), hepatitis C virus, human immunodeficiency virus-I and -II positive status.   Dated and signed IEC/IRB-approved informed consent. Exclusion Criteria:   Prior therapy for metastatic TNBC (chemotherapy, hormone therapy or biological therapy), Patients may receive bisphosphonates and other therapies to treat bone metastases, however if used, bone lesions will not be considered as measurable disease.   Less than four weeks since last radiotherapy (excluding palliative radiotherapy).   Pregnancy or lactation or unwillingness to use adequate method of birth control.   Neurological or psychiatric disorders which may influence understanding of study and informed consent procedures.   Active or uncontrolled infection.   Malabsorption syndrome, disease significantly affecting gastrointestinal function.   G>1 pre-existing peripheral neuropathy   Any other invasive malignancy from which the patient has been disease-free for less than 5 years with the exception of curatively treated basal or squamous cell skin cancer   Hypersensitivity to:   paclitaxel   ibuprofen or to more than one non-steroidal anti-inflammatory drug.   medications belonging to the class of sulfonamides, with the exception of sulfanilamides (e.g., sulfamethoxazole).