Celecoxib in Preventing Breast Cancer in At-Risk Premenopausal Women
RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing breast cancer in at-risk women.
PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing breast cancer in premenopausal women who are at risk of developing cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Study to Identify Biomarker Modulation by a Cyclooxygenase-2 (COX-2) Inhibitor in Breast Tissue of Premenopausal Women at High Risk for Estrogen Receptor Negative (ERN) Breast Cancer|
|Study Start Date:||January 2003|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Experimental: Celecoxib 400 mg bid
Celecoxib 400 mg bid
Celecoxib daily for 12 months
Other Name: Celebrex
- Determine the change in proliferation in benign breast epithelial cells as measured by Ki-67/MIB-1 in premenopausal women at high risk for estrogen receptor-negative breast cancer treated with celecoxib.
- Determine the feasibility of this regimen by dropout rate of these patients during 12 months of treatment and compliance.
- Determine the proportion of these women likely to express cyclooxygenase-2 protein (COX-2) in at least 10% of benign ductal epithelial cells.
- Compare the success rate of obtaining adequate ductal epithelial cells by random periareolar fine needle aspiration (FNA) and ductal lavage in these patients before vs after 12 months of a prevention intervention.
- Assess pain associated with FNA and ductal lavage in these women.
- Correlate, if possible, serum proteomics pattern with cytologic assessment and mammographic density at baseline and at 12 months in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral celecoxib twice daily. Treatment continues for 12 months in the absence of clinical evidence of cancer confirmed by biopsy or unacceptable toxicity.
Patients are assessed at baseline and at 12 months for mammographic breast density, serum hormone levels, and serum IGF-1/IGFBP-3. Patients undergo ductal lavage or fine needle aspiration for assessment of supernatant proteomics and breast biomarkers.
Patients are followed at 2 weeks and then annually for 5 years.
PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 10-14 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056082
|United States, Illinois|
|Lynn Sage Comprehensive Breast Center at Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|United States, Kansas|
|Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160-7820|
|United States, Oklahoma|
|Oklahoma University Medical Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Study Chair:||Carol J. Fabian, MD||University of Kansas|