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

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