Spots Global Cancer Trial Database for Vinorelbine and Docetaxel in Treating Women With Metastatic Breast Cancer

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Trial Identification

Brief Title: Vinorelbine and Docetaxel in Treating Women With Metastatic Breast Cancer

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

Study ID: NCT00006682

Conditions

Breast Cancer

Interventions

docetaxel

vinorelbine ditartrate

Study Description

Brief Summary: 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.

Detailed Description: 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.