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

About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring recurrent breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IV breast cancer, male breast cancer
Eligibility Criteria
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
Sites / Locations
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
Arms of the Study
Arm 1
Experimental
Sequential epirubicin/vinorelbine
For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.