Combination Chemotherapy With Trastuzumab in Treating Women With Metastatic Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed metastatic breast cancer c-erbB2 positive (3+ overexpression by the HercepTest™ method) in the primary tumor or metastatic site
• •At least 1 unidimensionally measurable target lesion
• •* At least 20 mm by conventional techniques OR
• •* At least 10 mm by spiral CT scan
• •* Lesions that have been irradiated in the preceding 3 months cannot be used as target lesions unless they have appeared or clearly progressed since prior irradiation
• •* No bone lesions as the only target lesions
• •No contralateral breast cancer that is c-erbB2-positive or c-erbB2-negative/unknown, with status determined on a metastatic site
• •No CNS metastases
• •* CT scan of brain and CSF cytology are required if neurologic symptoms are present
• •Hormone receptor status:
• •* Any estrogen or progesterone receptor status
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Sex:
• •Female
• •Menopausal status:
• •Any status
• •Performance status:
• •ECOG 0-2
• •Life expectancy:
• •Not specified
• •Hematopoietic:
• •Neutrophil count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hepatic:
• •Bilirubin no greater than 1.25 times upper limit of normal (ULN)
• •Transaminases less than 2.5 times ULN (5 times ULN if liver metastases present)
• •Renal:
• •For patients age 18 to 69:
• •* Creatinine no greater than ULN
• •For patients age 70 and over:
• •* Creatinine clearance normal
• •Cardiovascular:
• •LVEF normal by MUGA or echocardiogram
• •No clinical heart failure
• •Pulmonary:
• •No malignancy-associated dyspnea at rest
• •No requirement for supportive oxygen therapy
• •Other:
• •Not pregnant or nursing
• •No other prior or concurrent malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell skin cancer
• •No psychological, familial, sociological, or geographical condition that would preclude compliance with study therapy and follow-up schedule
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •No prior anti-c-erbB2 antibody, including trastuzumab (Herceptin®)
• •No other concurrent biologic therapy
• •Chemotherapy:
• •No more than 1 prior chemotherapy regimen for metastatic breast cancer
• •Prior combination of cyclophosphamide, methotrexate, and fluorouracil (CMF) allowed in the adjuvant or metastatic setting only if the disease-free interval after completion of CMF was at least 12 months
• •Prior anthracyclines and/or taxanes allowed
• •At least 4 weeks since prior anthracyclines
• •No prior cumulative dose of doxorubicin more than 360 mg/m\^2
• •No prior cumulative dose of epirubicin more than 720 mg/m\^2
• •No prior cumulative dose of mitoxantrone more than 90 mg/m\^2
• •No other concurrent chemotherapy
• •Endocrine therapy:
• •More than 2 weeks since prior hormonal therapy in the adjuvant or metastatic setting
• •No concurrent hormonal therapy
• •Radiotherapy:
• •See Disease Characteristics
• •No concurrent radiotherapy
• •Surgery:
• •Not specified
• •Other:
• •No other concurrent anticancer therapy or investigational drugs
• •No concurrent bisphosphonates started after study enrollment except for hypercalcemia