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

Date de début de l'étude : 1 avril 1999

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