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