Breast Cancer Clinical Trial
Official title:
Phase II Trial of Vinfluinine and Capecitabine in Previously Treated Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as vinflunine and capecitabine, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor
cells.
PURPOSE: This phase II trial is studying how well giving vinflunine together with
capecitabine works in treating patients with previously treated metastatic breast cancer.
OBJECTIVES:
Primary
- Evaluate the tumor response rate in patients with previously treated metastatic breast
cancer treated with vinflunine and capecitabine.
Secondary
- Describe the adverse event profile of this regimen in these patients.
- Determine the progression-free survival of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the duration of response in patients treated with this regimen.
- Determine the time to treatment failure in patients treated with this regimen.
- Describe the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive vinflunine IV over 20 minutes on day 1 and oral capecitabine twice daily on
days 1-14. Treatment repeats every 21 days in the absence of disease progression or
unacceptable toxicity.
Quality of life is assessed at baseline, every other course, and at the completion of study
treatment.
After completion of study treatment, patients are followed periodically for up to 5 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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