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

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 bone-only disease are not eligible
• Ineligible if currently experiencing a complete or partial response to prior hormonal therapy
• 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