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
Alliance for Clinical Trials in Oncology
With
OBJECTIVES: Primary * Compare the progression-free survival of women with metastatic or recurrent breast cancer treated with 2 dose levels of celecoxib. Secondary * Compare the side effects of the 2 dose levels of this drug in these patients. * Compare the overall survival of patients treated with the 2 dose levels of this drug. OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to disease status at study entry (complete response vs partial response vs stable) and prior metastatic/recurrent chemotherapy regimens (1 vs 2). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral high-dose celecoxib twice daily. * Arm II: Patients receive oral low-dose celecoxib twice daily. In both arms, treatment continues until first disease progression. At disease progression, treatment assignment is unblinded and treatment may continue at the treating physician's discretion. Patients initially randomized to the low-dose arm may either continue on that dosage or crossover to the high-dose arm. Patients initially randomized to the high-dose arm may continue on that dosage. Treatment after disease progression may continue for up to 12 months. Patients are followed every 3 months for 1 year and then every 6 months for up to 4 years. PROJECTED ACCRUAL: A total of 132 patients (88 in the high-dose arm and 44 in the low-dose arm) will be accrued for this study within 22 months.
Age
18–120
Sex
FEMALE
Healthy volunteers
Not accepted
