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

Fred Hutchinson Cancer Center (FHCC)

Status

Completed

Conditions

Mammographic Breast Density

Treatments

Drug: Placebo

Drug: Aspirin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00470561

CDR0000544639 (Registry Identifier)

PHS 1908.00

FHCRC-1908

FHCRC-PHS-1908.00

Details and patient eligibility

About

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.

Full 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.

Enrollment

144 patients

Sex

Female

Ages

55 to 75 years old

Volunteers

Accepts Healthy Volunteers

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