RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of vinorelbine combined with docetaxel in treating women who have metastatic breast cancer.
OBJECTIVES: I. Determine the response rate in women with metastatic breast cancer treated with vinorelbine and docetaxel. II. Determine the time to disease progression, time to treatment failure, response duration, and survival in this patient population treated with this regimen. OUTLINE: This is a multicenter study. Patients receive vinorelbine IV on days 1 and 8, and docetaxel IV over 1 hour on day 1 only. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed for 1 month, and then every 1.5-3 months for 1 year. PROJECTED ACCRUAL: Approximately 69 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Docetaxel 70mg/m2 on day 1 of every 21-day cycle
Navelbine 20mg/m2 on Day 1 and D8 of a 21-day cycle
Washington Cancer Institute
Washington D.C., District of Columbia, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
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