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

Completed · Not applicable · Has a placebo group

Conditions studied: Mammographic Breast Density

In brief

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.

Key facts

Study ID

NCT00470561

Run by

Fred Hutchinson Cancer Center

People needed

144

Starts

2005-11-01

Expected to finish

2007-07-01

Last updated by the study team

2010-11-15

Who can join

Age: 55 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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