Spots Global Cancer Trial Database for Protocol for Women at Increased Risk of Developing Breast Cancer

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Trial Identification

Brief Title: Protocol for Women at Increased Risk of Developing Breast Cancer

Official Title: 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

Study ID: NCT00291694

Conditions

Breast Cancer

Interventions

celecoxib

placebo

Study Description

Brief Summary: To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed.

Detailed Description: 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.