Statement: Patients with radiologically confirmed metatases in the CNS are excluded from both the secondary trial and the primary trial.
Primary_evidence: DISEASE CHARACTERISTICS: Inclusion criteria:   Histologically proven invasive unilateral breast cancer (regardless of the type)   Initial clinical condition compatible with complete initial resection   No residual macro or microscopic tumor after surgical excision   Node-positive disease (i.e., positive sentinel node or positive axillary clearance) (N+) or node-negative disease (-) meeting the following criteria :   Stage II or III disease   pT >20 mm (T1-4)   Patients must meet 1 of the following hormone-receptor criteria:   Node-positive patients: triple-negative* tumor (HER2 negative, estrogen-receptor [ER] negative, and progesterone receptor [PR] negative) OR double-negative (HER2 negative, PR negative, and ER+)   Node-negative patients: triple-negative* tumor only   NOTE: *Hormone-receptor negativity is defined as ER <10% and PR <10% by IHC and HER2 negativity is defined as IHC 0-1+ OR IHC 2+ and FISH or CISH negative   Must be able to begin chemotherapy no later than day 49 after the initial surgery Exclusion criteria:   Clinically or radiologically detectable metastases (M0)   Bilateral breast cancer or contralateral ductal carcinoma in situ   Any metastatic impairment, including homolateral subclavicular node involvement, regardless of its type   Any tumor T4a (cutaneous invasion, deep adherence, inflammatory breast cancer)   HER 2 overexpression defined as IHC 3+ OR IHC 2+ and FISH or CISH positive   Any clinically or radiologically suspect and non-explored damage to the contralateral breast   PATIENT CHARACTERISTICS: Inclusion criteria:   Female   Pre- or postmenopausal   ECOG performance status 0-1   Peripheral neuropathy grade 1   Neutrophil count 2,000/mm³   Platelet count 100,000/mm³   Hemoglobin >9 g/dL   AST and ALT 1.5 times upper limit of normal (ULN)   Alkaline phosphatase 2.5 times ULN   Total bilirubin 1.0 times ULN   Serum creatinine 1.5 times ULN   LVEF 50% by MUGA scan or echocardiography   Not pregnant or nursing   Negative pregnancy test   Fertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment Exclusion criteria:   Previous cancer (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma) in the preceding 5 years, including invasive contralateral breast cancer   Patients with any other concurrent severe and/or uncontrolled medical disease or infection that could compromise participation in the study   Clinically significant cardiovascular disease within the past 6 months including any of the following:   Unstable angina   Congestive heart failure   Uncontrolled hypertension (i.e., blood pressure >150/90 mm Hg)   Myocardial infarction   Cerebral vascular accidents   Known prior severe hypersensitivity reactions to agents containing Cremophor EL   Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule   Patients deprived of liberty or placed under the authority of a tutor   PRIOR CONCURRENT THERAPY:   At least 2 weeks since prior minor surgery (excluding breast biopsy) and adequately recovered   At least 3 weeks since prior major surgery and adequately recovered   No prior chemotherapy, hormonal therapy, or radiotherapy   More than 72 hours since prior and no concurrent treatment with any of the following strong inhibitors of CYP3A4:   Amiodarone   Clarithromycin   Amprenavir   Delavirdine   Voriconazole   Erythromycin   Fluconazole   Itraconazole   Ketoconazole   Indinavir   Nelfinavir   Ritonavir   Saquinavir   No concurrent participation in another therapeutic trial involving an experimental drug
Secondary_evidence: Inclusion Criteria:   Histologically confirmed breast cancer with evidence of metastatic disease   HER2 3+ or FISH (fluorescent in situ hybridization)+   Age  18 years   No prior trastuzumab, except as given in the adjuvant or neoadjuvant setting.   No prior chemotherapy in the metastatic setting. Exclusion Criteria:   CNS (central nervous system) metastases   Prior radiation therapy within the last 4 weeks   Pregnant (positive pregnancy test) or lactating women   Major surgical procedure, open biopsy, non-healing wounds, or significant traumatic injury within 28 days prior to starting study or anticipation of need for major surgical procedure during the study   Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to start of study.