Statement: There is no maximum or minimum age defined for participation in the primary trial or the secondary trial.
Primary_evidence: Inclusion Criteria:   Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.   ECOG performance status of 0 or 1   For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception   For patients who have received recent radiotherapy, recovery prior to randomization from any significant acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization Exclusion Criteria:   Disease-Specific Exclusions:   HER2-positive status   Prior chemotherapy for locally recurrent or metastatic disease   Prior hormonal therapy < 2 weeks prior to randomization   Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization   Investigational therapy within 28 days of randomization   General Medical Exclusions:   Life expectancy of < 12 weeks   Inadequate organ function   Uncontrolled serious medical or psychiatric illness   Active infection requiring intravenous (IV) antibiotics at screening   Pregnancy or lactation   History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death
Secondary_evidence: DISEASE CHARACTERISTICS:   Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma   Largest tumor lesion  5 cm   Palpable or nonpalpable breast lesion   Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions   Prior (preoperative) or planned (intraoperative) sentinel node biopsy required   At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension   No clinical evidence of distant metastases   No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following:   Skeletal pain of unknown cause   Elevated alkaline phosphatase   Bone scan showing hot spots   No palpable axillary lymph node(s)   No Paget's disease without invasive cancer   Hormone receptor status:   Estrogen receptor and progesterone receptor known   PATIENT CHARACTERISTICS:   Age   Any age   Sex   Female   Menopausal status   Any status   Performance status   Not specified   Life expectancy   Not specified   Hematopoietic   Not specified   Hepatic   See Disease Characteristics   Renal   Not specified   Other   Not pregnant or nursing   No other prior or concurrent malignancy except the following:   Adequately treated basal cell or squamous cell skin cancer   Adequately treated carcinoma in situ of the cervix   Adequately treated in situ melanoma   Contralateral or ipsilateral carcinoma in situ of the breast   No psychiatric, addictive, or other disorder that may compromise ability to give informed consent   Geographically accessible for follow-up   PRIOR CONCURRENT THERAPY:   Biologic therapy   Not specified   Chemotherapy   Not specified   Endocrine therapy   Not specified   Radiotherapy   Not specified   Surgery   See Disease Characteristics   Other   No prior systemic therapy for breast cancer   More than 1 year since prior chemopreventive agent