Breast Cancer Clinical Trial
Official title:
A Randomized, Phase II Trial of Weekly Taxol (Paclitaxel) Versus Weekly Taxol Plus Paraplatin (Carboplatin) as First-Line Chemotherapy in Patients Age 65 Years or Older With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. It is not yet known if paclitaxel is more effective with or
without carboplatin in treating stage IV breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with or
without carboplatin in treating women who have stage IV breast cancer.
OBJECTIVES:
- Compare the objective response rate in women treated with paclitaxel with or without
carboplatin as first-line chemotherapy for metastatic breast cancer.
- Compare the overall survival, time to disease progression, and duration of response in
these patients treated with these regimens.
- Compare the safety of these regimens in this patient population.
- Compare the quality of life of these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
adjuvant chemotherapy (yes vs no) and ECOG performance status (0-1 vs 2). Patients are
randomized to one of two treatment arms.
- Arm I: Patients receive paclitaxel IV over 1 hour weekly for 3 weeks.
- Arm II:Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes
weekly for 3 weeks.
Treatment in both arms continues every 4 weeks in the absence of disease progression or
unacceptable toxicity.
Quality of life is assessed at baseline, before each course during study, and then after
completion of study.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Treatment
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