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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aspirin

Criteria

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