Protocol for Women at Increased Risk of Developing Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Other: placebo; Drug: celecoxib

• Registration Number: NCT00291694
• Lead Sponsor: Carol Fabian, MD

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.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2006-02-10
• Study First Submitted QC: 2006-02-10
• Study First Posted: 2006-02-14
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2013-06-24
• Results First Submitted QC: 2013-06-24
• Results First Posted: 2013-09-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-16
• Last Update Posted: 2016-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	Matched blinded placebo twice daily for 12 months
1	celecoxib	Oral Celecoxib 400 mg twice daily for 12 months

Primary Outcome Measures

Name	Time	Method
Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67	Baseline and 12 months	Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.

Secondary Outcome Measures

Name	Time	Method
Serum Estradiol Concentration	Baseline to 12 months	Change in serum estradiol concentration
Molecular Ratio of Serum Concentration of IGF-1 to IGFBP3	baseline to 12 months	Change ion ratio.
Mammographic Breast Density	Baseline and 12 months	The percent of mammographic breast area that is considered to be at increased density. Evaluated using the semi-automated computer program Cumulus.
Serum Sex Hormone Binding Globulin (SHBG) Concentration	Baseline to 12 months	Change in serum concentration

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States