S0102: Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed stage IV carcinoma of the breast
• •HER-2 negative
• •* 0 or 1+ DAKO (2+ DAKO allowed if fluorescence in situ hybridization \[FISH\] negative)
• •* Weak or no staining on immunohistochemistry test
• •* No amplification by FISH
• •No effusions or ascites as only site of disease
• •No brain or CNS disease or metastases
• •Hormone receptor status:
• •* Not specified
• •PATIENT CHARACTERISTICS:
• •Age:
• •Not specified
• •Sex:
• •Female
• •Menopausal status:
• •Not specified
• •Performance status:
• •Zubrod 0-2
• •Hematopoietic:
• •Absolute neutrophil count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hepatic:
• •Bilirubin no greater than upper limit of normal (ULN)
• •SGOT or SGPT no greater than 1.5 times ULN
• •Alkaline phosphatase no greater than 2.5 times ULN
• •Renal:
• •Not specified
• •Other:
• •No clinically significant pre-existing grade 2 or greater motor or sensory peripheral neuropathy unless due to cancer
• •No known sensitivity to E. coli-derived proteins
• •No prior severe hypersensitivity reaction to 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 adequately treated stage I or II cancer currently in complete remission
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •Not specified
• •Chemotherapy:
• •No prior chemotherapy other than 1 prior adjuvant or neoadjuvant chemotherapy program for primary disease
• •At least 6 months since prior chemotherapy
• •Prior adjuvant anthracycline allowed
• •No prior taxanes (docetaxel or paclitaxel)
• •Endocrine therapy:
• •Prior adjuvant hormonal therapy for metastatic disease allowed
• •No concurrent hormonal therapy
• •Radiotherapy:
• •At least 3 weeks since prior radiotherapy
• •Surgery:
• •At least 2 weeks since prior surgery and recovered