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

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