Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|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|
|Study Start Date:||January 2001|
- 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.
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|Study Chair:||Edith A. Perez, MD||Mayo Clinic|