Breast Cancer Clinical Trial
Official title:
An Open-Label Phase II Study of Navelbine (Vinorelbine Tartrate) and Taxotere (Docetaxel) as First-Line Therapy for Metastatic Breast Cancer
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.
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