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Effect of Aspirin on Mammogram Density in Healthy Postmenopausal Women With a Moderate or High Level of Breast Density
This study is ongoing, but not recruiting participants.
First Received: May 3, 2007   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00470561
  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
Breast Cancer
Healthy, no Evidence of Disease
Drug: acetylsalicylic acid
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Procedure: breast imaging study
Procedure: mammography

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Mammography
Drug Information available for: Acetylsalicylic acid
U.S. FDA Resources
Study Type: Observational
Official Title: The Effect of Aspirin on Mammogram Density (TEAM)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Comparison of the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density

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
  • Adverse events
  • Putative biomarkers of breast and ovarian cancer

Estimated Enrollment: 144
Study Start Date: April 2007
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 Hutchison Cancer Research Center Ovarian SPORE activities.

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

DISEASE CHARACTERISTICS:

  • 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
  • No history of breast cancer, including ductal carcinoma in situ or lobular carcinoma in situ
  • Healthy without serious comorbidities

PATIENT CHARACTERISTICS:

  • Female
  • Postmenopausal
  • No history of illness for which NSAIDs are typically primary therapy (e.g., rheumatoid arthritis)
  • No allergy to NSAIDs
  • No anemia (hematocrit < 35%), abnormal bleeding tests, or bleeding disorders
  • No gastrointestinal (GI) ulcer or history of GI bleeding
  • No adverse reactions to aspirin acid or other NSAIDs
  • No renal disease
  • No asthma
  • No current or chronic liver disease
  • No history of hemorrhagic stroke or transient ischemic attack
  • No 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
  • No 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)
  • No documented carotid artery disease
  • No diabetes
  • No uncontrolled hypertension
  • No planned extensive weight loss in the next 6 months (≥ 10 pounds)
  • Less than 2 alcoholic drinks daily
  • No mental illness or alcohol or drug abuse

PRIOR CONCURRENT THERAPY:

  • 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
  • No prior angioplasty or coronary artery bypass grafting
  • No prior breast implantation or reduction surgery
  • More than 6 months since prior hormones for menopause (including pills, patches, vaginal route), tamoxifen citrate, raloxifene, other hormonal therapy, or herbal or soy preparations
  • No 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
Investigators
Study Chair: Nicole Urban, ScD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000544639, FHCRC-PHS-1908.00, FHCRC-1908
Study First Received: May 3, 2007
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00470561     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
breast cancer
healthy, no evidence of disease

Study placed in the following topic categories:
Anti-Inflammatory Agents
Skin Diseases
Cyclooxygenase Inhibitors
Breast Neoplasms
Fibrinolytic Agents
Cardiovascular Agents
Healthy
Fibrin Modulating Agents
Aspirin
Analgesics, Non-Narcotic
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Breast Diseases

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Neoplasms by Site
Aspirin
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Breast Diseases
Skin Diseases
Cyclooxygenase Inhibitors
Breast Neoplasms
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Neoplasms
Analgesics, Non-Narcotic
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009