| Original Study ID : 9118 |
| NCT ID : NCT00291694 |
| 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 |
| 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. |
| Source : University of Kansas |
| 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. |
| Overall Status : Active, not recruiting |
| Start Date : April 2003 |
| End Date : June 2009 |
| Completion Date : June 2009 |
| Official Title : Phase 2 |
| Phase : Interventional |
| Study Design : Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Enrollment : 72 |
| Verification Date : September 2008 |
| First Received Date : February 10, 2006 |
| Trial Eligibility |
| Criteria : Inclusion Criteria: - women who have a high risk of breast cancer - older than 18 years Exclusion Criteria: - anticoagulants - marked breast tenderness - pregnant or within twelve months of breast feeding/childbirth |
| Gender : Female |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : Accepts He |
| Facilities |
| Facility Name : University of Kansas Medical Center |
| City : Kansas City |
| State : Kansas |
| Zip Code : 66160 |
| Country : United States |
| OutComes |
| Primary OutComes |
| Measure : Cytology of breast tissue aspirate using standard scoring methods and the Masood scoring system. |
| Time Frame : baseline, 12 months |
| Safety issue : No |
| Secondary OutComes |
| Measure : serum markers for hormones and growth factors, mammographic breast density |
| Time Frame : Baseline and 12 months |
| Safety issue : No |
| Interventions |
| Type : Drug |
| Name : celecoxib |
| Description : Celecoxib 400 mg BID |
| Type : Other |
| Name : placebo |
| Description : placebo |
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