Randomized Phase II Trial of Paclitaxel, Carboplatin and rhuMAb Her-2 (Herceptin) as First-Line Chemotherapy in Patients With Metastatic Breast Cancer Who Overexpress Her-2

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic adenocarcinoma of the breast

- Strong overexpression of HER-2 by immunohistochemistry (3+)

- 0-2+ tumors allowed if demonstrate amplification by FISH

- Bidimensionally measurable disease

- Brain metastasis must not represent sole site of disease

- No untreated brain metastasis receiving radiotherapy

- Previously treated brain metastases in continued response to radiotherapy and/or
surgery for at least 2 months allowed

- Hormone receptor status:

- Positive or negative

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Female

Menopausal status:

- Not specified

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 mg/dL

- AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver
metastases present)

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No myocardial infarction within the past 6 months

- No congestive heart failure or unstable angina

- No clinically significant pericardial effusion or arrhythmia

Other:

- No other invasive malignancy within the past 5 years except curatively treated basal
cell or squamous cell skin cancer or carcinoma in situ of the cervix

- No active uncontrolled infection

- No prior allergic reaction to Cremophor EL, anesthetics, or muscle relaxants

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent filgrastim (G-CSF)

Chemotherapy:

- Prior adjuvant chemotherapy allowed

- Prior taxane therapy allowed

- No prior cisplatin or carboplatin

- No prior chemotherapy for metastatic disease

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- No prior radiotherapy to more than 25% of marrow

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- At least 4 weeks since prior surgery and recovered

Other:

- At least 7 days since prior parenteral antibiotics