Effect of Aspirin on Mammogram Density in Healthy Postmenopausal Women With a Moderate or High Level of Breast Density

Not Applicable

Completed

• Conditions: Mammographic Breast Density
• Interventions: Drug: Aspirin; Drug: Placebo

• Registration Number: NCT00470561
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

RATIONALE: Aspirin may be effective in reducing breast density in healthy postmenopausal women with a moderate or high level of breast density.

PURPOSE: This randomized clinical trial is studying the effect of aspirin on mammogram density compared with a placebo in healthy postmenopausal women with a moderate or high level of breast density.

Detailed Description

OBJECTIVES:

Primary

* Compare the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density in healthy postmenopausal women with a moderate or high level of breast density.

Secondary

* Determine whether there is a differential response in mammogram density to aspirin treatments in individual homozygous wild-type, heterozygous, and homozygous variant for several UGT gene polymorphisms.

* Determine the effect of aspirin therapy on potential adverse events, including gastrointestinal symptoms and signs, bleeding events, blood pressure, and other major comorbidities and hospitalizations, as well as generalized symptoms, in these participants.

* Determine the effects of aspirin therapy on putative biomarkers of breast and ovarian cancer that are currently being validated as part of ongoing Fred Hutchinson Cancer Research Center Ovarian SPORE activities.

* Determine the effects of aspirin therapy on levels of serum estradiol, estrone and sex hormone binding globulin (SHBG) as measured by radioimmunoassay at baseline and 6 month timepoints

OUTLINE: This is a randomized, placebo-controlled, double-blind study. Participants are randomized to 1 of 2 treatment arms.

* Arm I: Participants receive oral acetylsalicylic acid (aspirin) daily for 6 months.

* Arm II: Participants receive oral placebo daily for 6 months. In both arms, participants undergo a repeat mammogram at 6 months.

Blood and urine samples are collected at baseline and at 6 months. Single-nucleotide polymorphisms in the UGT genes and variable number of tandem repeat-type polymorphisms are genotyped.

PROJECTED ACCRUAL: A total of 144 participants will be accrued for this study.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-07
• Primary Completion: 2007-06
• Study Completion: 2007-07
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-10
• Last Update Posted: 2010-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin	Aspirin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Comparison of the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density	Baseline and end-of-study (6 month timepoint)

Secondary Outcome Measures

Name	Time	Method
Differential response in mammogram density to aspirin treatments in individual homozygous wild-type, heterozygous, and homozygous variant for several UGT gene polymorphisms	Baseline and end-of-study (6 month timepoint)	Changes at baseline and 6 month timepoint in mammographic density; measurements of single numcleotide polymorphisms in specific genes from a single DNA samples
Adverse events	Collected over the course of tehestudy
Putative biomarkers of breast and ovarian cancer	Baseline and end-of-study (6 month timepoint)
Comparison of the effect of aspiring vs placebo on serum levels of estradiol, estrone and sex hormone binding globulin	Baseline and 6 month timepoints

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States