s0102: docetaxel, vinorelbine, and filgrastim in treating women with stage iv breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. purpose: phase ii trial to study the effectiveness of combining docetaxel, vinorelbine, and filgrastim in treating women who have stage iv breast cancer.

objectives: * determine the 1-year survival of women with her-2-negative stage iv breast cancer treated with docetaxel, vinorelbine, and filgrastim (g-csf). * determine the response rate (both complete and partial response) and time to progression in patients treated with this regimen. * determine the qualitative and quantitative toxic effects of this regimen in this patient population. outline: this is a multicenter study. patients receive docetaxel iv over 1 hour on day 1, vinorelbine iv over 6-10 minutes on days 8 and 15, and filgrastim (g-csf) subcutaneously on days 2-21. treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. patients are followed every 6 months for 3 years. projected accrual: a total of 90 patients will be accrued for this study within 4-5 months.

Eligibility 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

Keywords: stage iv breast cancer recurrent breast cancer