Protocol for Women at Increased Risk of Developing Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291694
• Other study ID #: 9118
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2006
• Last updated: October 30, 2015
• Start date: April 2003
• Est. completion date: December 2009

Study information

• Verified date: October 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• celecoxib
Celecoxib 400 mg BID

Other:
• placebo
placebo

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Carol Fabian, MD	Susan G. Komen Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Value of Ki-67		Baseline and 12 months	No
Secondary	Serum Markers for Hormones and Growth Factors, Mammographic Breast Density		Baseline and 12 months	No