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

Mammographic Breast Density Clinical Trial

Official title:

The Effect of Aspirin on Mammogram Density (TEAM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470561
• Other study ID #: PHS 1908.00
• Secondary ID: FHCRC-PHS-1908.0
• Status: Completed
• Phase: N/A
• First received: May 3, 2007
• Last updated: November 10, 2010
• Start date: November 2005
• Est. completion date: July 2007

Study information

• Verified date: November 2010
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00464906

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: July 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Mammographic Breast Density

Intervention

Drug:
• Aspirin
Two 325 mg doses of aspirin per day for 6 months
• Placebo
Two placebo pills per day for 6 months

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density		Baseline and end-of-study (6 month timepoint)	No
Secondary	Differential response in mammogram density to aspirin treatments in individual homozygous wild-type, heterozygous, and homozygous variant for several UGT gene polymorphisms	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)	No
Secondary	Adverse events		Collected over the course of tehestudy	Yes
Secondary	Putative biomarkers of breast and ovarian cancer		Baseline and end-of-study (6 month timepoint)	No
Secondary	Comparison of the effect of aspiring vs placebo on serum levels of estradiol, estrone and sex hormone binding globulin		Baseline and 6 month timepoints	No