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
- 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
Masking: Open Label, Primary Purpose: Prevention
Carol J. Fabian, MD
University of Kansas
United States: Federal Government
|Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center||Kansas City, Kansas 66160-7353|
|Oklahoma University Medical Center||Oklahoma City, Oklahoma 73104|
|Lynn Sage Comprehensive Breast Center at Northwestern Memorial Hospital||Chicago, Illinois 60611|