Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed breast cancer
• * Must have clinical evidence of stage IV (M1) disease
• HER-2/neu negative (0, 1+, or 2+ by immunohistochemistry or fluorescent in situ hybridization) OR status unknown
• At least 1 measurable lesion
• * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• Patients with disease progression after prior response to hormonal therapy are eligible
• Disease progression without prior hormonal therapy is allowed
• Stable or asymptomatic brain metastasis allowed if:
• * Other measurable disease exists
• * Cranial irradiation completed and brain metastasis stable for at least 4 weeks before study
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Sex:
• Female
• Menopausal status:
• Pre- or post-menopausal
• Performance status:
• ECOG 0-2
• Life expectancy:
• At least 3 months
• Hematopoietic:
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hepatic:
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST and ALT no greater than 2 times ULN
• Renal:
• Creatinine no greater than 2 times ULN
• Corrected calcium less than 12 mg/dL
• Cardiovascular:
• No New York Heart Association class III or IV heart disease
• No documented myocardial infarction within the past 6 months
• No congestive heart failure
• No unstable angina
• No clinically significant pericardial effusion or arrhythmia
• Other:
• No active serious infection
• No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporine, or vitamin K
• No clinically significant (greater than grade 1) peripheral neuropathy
• No other serious underlying medical condition that would preclude study participation
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• More than 6 months since prior adjuvant bone marrow or peripheral blood stem cell transplantation
• More than 6 months since prior adjuvant monoclonal antibody therapy
• More than 6 months since prior adjuvant vaccine therapy
• No prior trastuzumab (Herceptin)
• No concurrent anticancer immunotherapy
• Chemotherapy:
• No prior chemotherapy for metastatic breast cancer
• More than 6 months since prior adjuvant high-dose chemotherapy
• More than 6 months since prior adjuvant taxanes or any other adjuvant chemotherapy
• Prior adjuvant taxanes allowed only if administered every 3 weeks
• Endocrine therapy:
• See Disease Characteristics
• Any number of prior hormonal therapies for metastatic breast cancer allowed
• * Patients with definite signs of progression may begin study therapy immediately after stopping hormonal therapy
• No concurrent anticancer hormonal agents (including megestrol)
• Radiotherapy:
• At least 3 weeks since prior radiotherapy (4 weeks for cranial irradiation)
• No prior radiotherapy to 30% or more of bone marrow
• No concurrent radiotherapy except for palliation of painful bone metastasis or pathologic fractures to the area of known lytic disease
• Surgery:
• At least 3 weeks since prior major surgery
• Other:
• More than 6 months since prior neoadjuvant therapy
• No other concurrent anticancer drugs