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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00470561
First received: May 3, 2007
Last updated: November 10, 2010
Last verified: November 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014