Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer
- 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
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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.
Powel H. Brown, MD, PhD
Baylor College of Medicine
United States: Food and Drug Administration
|Veterans Affairs Medical Center - Houston||Houston, Texas 77030|
|Swedish Cancer Institute at Swedish Medical Center - First Hill Campus||Seattle, Washington 98104|
|Baylor University Medical Center - Houston||Houston, Texas 77030-2399|
|University Cancer Center at University of Washington Medical Center||Seattle, Washington 98195|
|University of New Mexico Cancer Center||Albuquerque, New Mexico 87131-5636|
|Ben Taub General Hospital||Houston, Texas 77030|
|Methodist Hospital||Houston, Texas 77030|
|Glendale Memorial Hospital Comprehensive Cancer Center||Glendale, California 91204|
|St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital||Houston, Texas 77030|