Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- celecoxib
- Conditions
- Breast Cancer
- Sponsor
- SWOG Cancer Research Network
- Enrollment
- 8
- Locations
- 9
- Primary Endpoint
- Mammographic Density
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing breast cancer.
PURPOSE: This randomized phase II trial is studying how well celecoxib works in preventing breast cancer in premenopausal women who are at risk for developing the disease.
Detailed Description
OBJECTIVES: * Compare 1-year mammographic density in premenopausal women at high risk for developing breast cancer treated with celecoxib vs placebo. * Compare 1-year proliferation of breast epithelial cells, as measured by Ki67 staining, in patients treated with these drugs. * Compare the expression of other biomarkers, including cyclo-oxygenase-2 (COX-2) enzyme and a marker of apoptosis, in breast tissue of patients treated with these drugs. * Compare 1-year plasma levels of insulin-like growth factor (IGF)-1, IGF binding protein-3, and prostaglandin E_2 in patients treated with these drugs. * Compare the toxicity of these drugs in these patients. OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to risk category (lobular carcinoma in situ or ductal carcinoma in situ vs BRCA1/2 mutation AND any Gail risk vs Gail risk ≥1.7% but \< 5% vs Gail risk ≥ 5%) and prior tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Celocoxib: Patients receive oral celecoxib twice daily. * Placebo: Patients receive oral placebo twice daily. In both arms, treatment continues for 12 months in the absence of unacceptable toxicity or diagnosis of cancer. Patients are followed at 1 month. PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I - Celecoxib
Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Intervention: celecoxib
Arm II - Placebo
Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Intervention: placebo
Outcomes
Primary Outcomes
Mammographic Density
Time Frame: 1 year
The primary outcome measure is change in mammographic density. The null hypothesis is that there is no difference between the arms in change in mammographic density over one year versus the alternative that the treatment arm reduces mammographic density by 10 points (percent of pixels highlighted) or more over one year compared to the change in the placebo arm.
Secondary Outcomes
- Ki-67 Expression(1 year)