Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
M.D. Anderson Cancer Center
With
OBJECTIVES: * 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 patients. * Correlate pretreatment serum HER2/neu level and response with docetaxel therapy in these patients. 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 days. * 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 toxicity. 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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted