Breast Cancer Clinical Trial
Official title:
Docetaxel And Vinorelbine Plus Filgrastim For HER-2 Negative, Stage IV Breast Cancer
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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