Epirubicin and Vinorelbine in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed stage IIB (T3, N0), IIIA, IIIB, or IV breast carcinoma
• Original tumor must be available for analysis of p53 status
• Measurable disease, defined as any lesion that can be accurately measured in ≥ 1 dimension with longest diameter ≥ 20 mm using conventional techniques OR ≥ 10 mm with spiral CT scan
• * Stage IIIB disease will be assessed by clinical exam (monitoring skin changes as well as tumor size)
• No visceral crisis (lymphangitic pulmonary spread, or liver or marrow replacement sufficient to cause significant organ dysfunction)
• No untreated CNS metastases
• Hormone receptor status not specified
• PATIENT CHARACTERISTICS:
• Menopausal status not specified
• ECOG performance status 0-2
• Life expectancy ≥ 8 weeks
• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL
• Bilirubin normal
• AST ≤ 3 times normal (≤ 5 times normal if liver metastases are present)
• Creatinine ≤ 1.5 mg/dL
• Ejection fraction ≥ lower limit of normal by MUGA scan or ECG
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective nonhormonal contraception
• No other malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
• No pre-existing disease (i.e., cardiac, pulmonary, neurologic, or other disease) that the investigator judges to be clinically significant
• No active infectious process, severe malnutrition, or intractable emesis
• PRIOR CONCURRENT THERAPY:
• Recovered from all prior therapy
• At least 3 weeks since prior radiotherapy
• At least 3 weeks since prior chemotherapy
• * Maximum prior doxorubicin hydrochloride dose must be ≤ 300 mg/m² OR equivalent anthracycline (epirubicin hydrochloride) dose must be ≤ 540 mg/m² OR calculated total anthracycline dose must be ≤ 540 mg/m² (determined as 1.8 times total doxorubicin hydrochloride dose plus epirubicin hydrochloride dose)
• No prior chemotherapy for metastatic disease
• Prior adjuvant chemotherapy, radiotherapy, and/or hormonal therapy for breast cancer allowed
• No concurrent radiotherapy except for brain metastases