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

November 10, 2010 updated by: Fred Hutchinson Cancer Center

The Effect of Aspirin on Mammogram Density (TEAM)

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • Seattle, Washington, United States, 98109-1024
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

INCLUSION CRITERIA:

  • Moderate or high density breast tissue on mammogram within the past 4 months

    • Breast Imaging-Reporting and Data System (BIRAD) class 2-4 or digitized mammogram with ≥ 25% density
  • Healthy without serious comorbidities
  • Female
  • Postmenopausal
  • More than 3 weeks since prior and no other concurrent use (2 or more times per week) of acetylsalicylic acid (aspirin), ibuprofen, or other NSAIDs

EXCLUSION CRITERIA:

  • history of breast cancer, including ductal carcinoma in situ or lobular carcinoma in situ
  • history of illness for which NSAIDs are typically primary therapy (e.g., rheumatoid arthritis)
  • Allergy to NSAIDs
  • Anemia (hematocrit < 35%), abnormal bleeding tests, or bleeding disorders
  • Gastrointestinal (GI) ulcer or history of GI bleeding
  • Adverse reactions to aspirin acid or other NSAIDs
  • Renal disease
  • Asthma
  • Current or chronic liver disease
  • History of hemorrhagic stroke or transient ischemic attack
  • History of coronary artery disease, including any of the following:

    • Myocardial infarction (MI)
    • Angina
    • Coronary artery disease documented on cardiac catheterization, exercise thallium, or exercise echocardiogram
  • Strong family history of coronary artery disease (i.e., mother with MI before 55 years of age, father with MI before 45 years of age)
  • Documented carotid artery disease
  • Diabetes
  • Uncontrolled hypertension
  • No planned extensive weight loss in the next 6 months (≥ 10 pounds)
  • More than 2 alcoholic drinks daily
  • Mental illness or alcohol or drug abuse
  • Prior angioplasty or coronary artery bypass grafting
  • Prior breast implantation or reduction surgery
  • Less than 6 months since prior hormones for menopause (including pills, patches, vaginal route), tamoxifen citrate, raloxifene, other hormonal therapy, or herbal or soy preparations
  • Concurrent anticoagulation medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Two placebo pills per day for 6 months
Other Names:
  • Placebo, sugar pill
Active Comparator: Aspirin
Two 325 mg doses of aspirin per day for 6 months
Other Names:
  • Acetylsalicylic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density
Time Frame: Baseline and end-of-study (6 month timepoint)
Baseline and end-of-study (6 month timepoint)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differential response in mammogram density to aspirin treatments in individual homozygous wild-type, heterozygous, and homozygous variant for several UGT gene polymorphisms
Time Frame: 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
Baseline and end-of-study (6 month timepoint)
Adverse events
Time Frame: Collected over the course of tehestudy
Collected over the course of tehestudy
Putative biomarkers of breast and ovarian cancer
Time Frame: Baseline and end-of-study (6 month timepoint)
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
Time Frame: Baseline and 6 month timepoints
Baseline and 6 month timepoints

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Nicole Urban, ScD, Fred Hutchinson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

May 3, 2007

First Submitted That Met QC Criteria

May 3, 2007

First Posted (Estimate)

May 7, 2007

Study Record Updates

Last Update Posted (Estimate)

November 15, 2010

Last Update Submitted That Met QC Criteria

November 10, 2010

Last Verified

November 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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