NCT00088972

S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women

Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	celecoxib	Given orally
OTHER	placebo	Given orally

Timeline

• Start date: 2004-11-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2004-08-05
• Last updated: 2018-08-10
• Results posted: 2013-04-09

Locations

9 sites across 1 country: United States