NCT00291694

Protocol for Women at Increased Risk of Developing Breast Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Carol Fabian, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	celecoxib	Celecoxib 400 mg BID
OTHER	placebo	placebo

Timeline

• Start date: 2003-04-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2006-02-14
• Last updated: 2016-11-07
• Results posted: 2013-09-05

Locations

1 site across 1 country: United States