Phase III Study Comparing the Use of Docetaxel on a Every Three-Week vs. Weekly Schedule in the Treatment of Patients With Metastatic Breast Cancer
- Compare the objective tumor response rate, duration of response, time to progression,
progression-free survival, and overall survival in women with metastatic breast cancer
treated with docetaxel administered weekly vs every three weeks.
- Compare the safety and toxicity of these regimens in these patients.
- Evaluate the maintenance of relative dose intensity with each regimen in these
- Correlate pretreatment serum HER2/neu level and response with docetaxel therapy in
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
taxane use (yes vs no), number of prior chemotherapy regimens for metastatic disease (0 vs
1), and participating center. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21
- Arm II: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses
repeat every 28 days.
Treatment continues in both arms in the absence of disease progression or unacceptable
Patients are followed at 3 weeks, at 3, 6, 9, and 12 months, and then annually for 4 years.
PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Tumor Response Rate
Edgardo Rivera, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|MD Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|University of Texas M.D. Anderson CCOP Research Base||Houston, Texas 77030-4009|