Breast Cancer
Conditions
Keywords
stage IV breast cancer, recurrent breast cancer
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALfilgrastim
DRUGdocetaxel
DRUGvinorelbine
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed