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Clinical Trial Name - Protocol for Women at Increased Risk of Developing Breast Cancer

 
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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