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

Purpose

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.

Condition	Intervention
Mammographic Breast Density	Drug: Aspirin Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title:	The Effect of Aspirin on Mammogram Density (TEAM)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Mammography

Drug Information available for: Aspirin

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:

Comparison of the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density [ Time Frame: Baseline and end-of-study (6 month timepoint) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Differential response in mammogram density to aspirin treatments in individual homozygous wild-type, heterozygous, and homozygous variant for several UGT gene polymorphisms [ Time Frame: Baseline and end-of-study (6 month timepoint) ] [ Designated as safety issue: No ]
Changes at baseline and 6 month timepoint in mammographic density; measurements of single numcleotide polymorphisms in specific genes from a single DNA samples
Adverse events [ Time Frame: Collected over the course of tehestudy ] [ Designated as safety issue: Yes ]
Putative biomarkers of breast and ovarian cancer [ Time Frame: Baseline and end-of-study (6 month timepoint) ] [ Designated as safety issue: No ]
Comparison of the effect of aspiring vs placebo on serum levels of estradiol, estrone and sex hormone binding globulin [ Time Frame: Baseline and 6 month timepoints ] [ Designated as safety issue: No ]

Enrollment:	144
Study Start Date:	November 2005
Study Completion Date:	July 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Aspirin	Drug: Aspirin Two 325 mg doses of aspirin per day for 6 months Other Name: Acetylsalicylic acid
Placebo Comparator: Placebo	Drug: Placebo Two placebo pills per day for 6 months Other Name: Placebo, sugar pill

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.

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.

Eligibility

Ages Eligible for Study:	55 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470561

Locations

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Nicole Urban, ScD

Fred Hutchinson Cancer Research Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Anne McTiernan, MD PhD, FHCRC
ClinicalTrials.gov Identifier:	NCT00470561 History of Changes
Obsolete Identifiers:	NCT00464906
Other Study ID Numbers:	PHS 1908.00, FHCRC-PHS-1908.00, FHCRC-1908, CDR0000544639
Study First Received:	May 3, 2007
Last Updated:	November 10, 2010
Health Authority:	United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:

mammographic breast density aspirin

Additional relevant MeSH terms:

Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents

Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013