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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
objective response rate
Time frame: Up to 5 years
time to progression
Time frame: Up to 5 years
quality of life
Time frame: Up to 5 years
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