Status:
COMPLETED
Effect of Aspirin on Mammogram Density in Healthy Postmenopausal Women With a Moderate or High Level of Breast Density
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Mammographic Breast Density
Eligibility:
FEMALE
55-75 years
Phase:
NA
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...
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. Second...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00470561
Start Date
November 1 2005
End Date
July 1 2007
Last Update
November 15 2010
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024