A Double-blinded Phase II Study of the Expression of Ki-67/MIB-1 in Women With Hyperplasia of the Breast Randomized to Receive Daily Celecoxib 400 mg BID or Placebo
A blind randomized study of celecoxib in women at high risk of developing breast cancer.
Subjects are to take twelve months of drug/placebo. At baseline and after twelve months
subjects will have a random periareolar fine needle breast aspiration that will be assessed
for epithelial cell growth and other markers of risk. Baseline and twelve month serum
samples will also be assessed for hormones and growth factors which may be associated with
breast cancer risk. Mammograms at baseline and twelve months will also be assessed for
breast density changes.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Cytology of breast tissue aspirate using standard scoring methods and the Masood scoring system.
baseline, 12 months
Carol J Fabian, MD
University of Kansas
United States: Institutional Review Board
|University of Kansas Medical Center||Kansas City, Kansas 66160-7353|