S0215 Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IV breast cancer
• Metastasis to the ipsilateral supraclavicular lymph nodes allowed
• HER2-positive by fluorescence in situ hybridization (FISH) or immunohistochemistry 3+ staining confirmed in the adjuvant or metastatic setting
• No effusions or ascites as only sites of disease
• No primary or metastatic brain or central nervous system tumor
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin normal
• aspartate aminotransferase or Alanine aminotranferease no greater than 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Not specified

Cardiovascular:

• left ventricular ejection fraction normal by multigated radionuclide angiography or echocardiogram (patients who have received prior anthracycline therapy)
• No clinical evidence or history of cardiomyopathy

Other:

• No pre-existing grade 2 or greater motor or sensory peripheral neuropathy except abnormalities due to cancer
• No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80
• 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 other adequately treated stage I or II cancer currently in complete remission
• No known sensitivity to E. coli-derived proteins
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 6 months since prior chemotherapy
• Prior anthracycline as adjuvant therapy allowed
• No prior cumulative dose of doxorubicin more than 360 mg/m^2
• No prior cumulative dose of epirubicin more than 720 mg/m^2
• No more than 1 prior adjuvant or neoadjuvant chemotherapy regimen for primary disease
• No prior docetaxel
• No prior vinorelbine
• Prior paclitaxel allowed

Endocrine therapy:

• Prior hormonal therapy as adjuvant therapy or for metastatic breast cancer allowed
• No concurrent hormonal therapy

Radiotherapy:

• At least 3 weeks since prior radiotherapy

Surgery:

• At least 2 weeks since prior surgery and recovered