Vinorelbine With or Without Trastuzumab in Treating Women With Progressive Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed breast cancer
• * Clinical evidence of metastatic disease
• HER2-positive tumor, as indicated by one of the following methods:
• * HER2 gene amplification by fluorescence in situ hybridization
• * HER2 protein overexpression (3+) by immunohistochemistry
• Disease progression during or after prior taxane therapy (single-agent paclitaxel, docetaxel, or taxane-containing combination chemotherapy) in combination with trastuzumab (Herceptin®) as first- or second-line chemotherapy for metastatic disease
• * Patients who received maintenance therapy with single-agent trastuzumab after acheiving a response or stable disease to prior taxane/trastuzumab combination therapy are eligible provided disease has progressed
• Measurable or nonmeasurable disease
• * No effusions or ascites as the only sites of disease
• No leptomeningeal disease or lymphatic pulmonary metastases
• Brain metastases allowed provided disease is stable for \> 3 months after completion of prior radiotherapy to the brain
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Sex
• Female
• Menopausal status
• Not specified
• Performance status
• Zubrod 0-1
• Life expectancy
• Not specified
• Hematopoietic
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL
• Hepatic
• Bilirubin ≤ 2.0 mg/dL
• SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (\< 5 times ULN in the presence of liver metastases)
• Alkaline phosphatase ≤ 3 times ULN (\< 5 times ULN in the presence of liver or bone metastases)
• Renal
• Creatinine ≤ 2.0 mg/dL
• Calcium ≤ 11.0 mg/dL
• Cardiovascular
• No history of significant symptomatic cardiac disease
• LVEF ≥ 50% of the lower limit of normal by MUGA or ECG
• Other
• No pre-existing clinically significant (≥ grade 2) motor or sensory neuropathy except for abnormalities due to cancer
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• See Disease Characteristics
• At least 28 days since prior trastuzumab
• No concurrent filgrastim (G-CSF)
• Chemotherapy
• See Disease Characteristics
• No more than 2 prior chemotherapy regimens for metastatic breast cancer
• * Prior adjuvant/neoadjuvant chemotherapy allowed, for a total of 3 prior regimens
• No prior vinorelbine
• No other prior chemotherapy after progression on a taxane/trastuzumab regimen
• No prior cumulative dose \> 360 mg/m\^2 of anthracycline-based chemotherapy
• Endocrine therapy
• No prior hormonal therapy after progression on a taxane/trastuzumab regimen
• Prior exogenous hormonal therapy for stage IV disease and/or as adjuvant therapy allowed
• Radiotherapy
• See Disease Characteristics
• No prior radiotherapy to \> 50% of the marrow-bearing bone
• Surgery
• At least 4 weeks since prior major surgery (2 weeks for minor surgery) and recovered
• Other
• Concurrent bisphosphonates allowed for bone metastasis