Spots Global Cancer Trial Database for Vinorelbine in Treating Older Women With Stage IV Breast Cancer

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Trial Identification

Brief Title: Vinorelbine in Treating Older Women With Stage IV Breast Cancer

Official Title: Phase II Trial of Oral Vinorelbine for the Treatment of Metastatic Breast Cancer in Patients >65 Years of Age: A Trial of Efficacy, Toxicity, and Patients' Perceived Preference for Oral Therapy

Study ID: NCT00022152

Conditions

Breast Cancer

Interventions

vinorelbine tartrate

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating older women who have stage IV breast cancer.

Detailed Description: OBJECTIVES: * Determine the objective response rate in elderly women with stage IV breast cancer treated with oral vinorelbine. * Determine the toxicity profile of this drug in these patients. * Determine the time to progression in patients treated with this drug. * Determine the quality of life of patients treated with this drug. * Assess individual variation in responses (toxicity and/or activity), pharmacokinetic parameters, and/or biologic correlates due to genetic differences in enzymes involved in the transport, metabolism, and/or mechanism of action of this drug in these patients. OUTLINE: Patients receive oral vinorelbine once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then after completion of the second course. Patients are followed every 3 months for 5 years.