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Celecoxib for Breast Cancer Prevention in High-Risk Premenopausal Women
NCT00056082Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2003
- Primary completion
- Jul 2008
- Countries
- 1
- Sponsor
- University of Kansas Medical Center
- Modality
- Orthosteric Ligands
- Drugs
- celecoxib
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of celecoxib in breast cancer, sponsored by University of Kansas Medical Center. Primary endpoint: Change in proliferation in benign breast epithelial cells as measured by Ki-67/MIB-1 at 12 months. Started Jan 2003; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Celecoxib Arm
Celecoxib 400 mg bid
03
Who it enrols
Premenopausal women aged 18-55 at high risk for estrogen receptor-negative breast cancer (Gail risk, BRCA mutation, family history, or prior biopsy). Must have ER-negative status if prior cancer/biopsy. Excludes BMI > 33, diabetes, and history of CVD/DVT.
04
Endpoints
Primary
Change in proliferation in benign breast epithelial cells as measured by Ki-67/MIB-1
Secondary
Feasibility of regimen by dropout rate and compliance
Proportion of women expressing COX-2 in benign ductal epithelial cells
Success rate of obtaining adequate ductal epithelial cells by FNA vs ductal lavage
Pain associated with FNA and ductal lavage
Mammographic breast density
Serum IGF-1 and IGFBP-3 levels
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