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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00470561 |
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 |
Study Type: | Observational |
Official Title: | The Effect of Aspirin on Mammogram Density (TEAM) |
Estimated Enrollment: | 144 |
Study Start Date: | April 2007 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Participants are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | 55 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
Moderate or high density breast tissue on mammogram within the past 4 months
PATIENT CHARACTERISTICS:
No history of coronary artery disease, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109-1024 |
Study Chair: | Nicole Urban, ScD | Fred Hutchinson Cancer Research Center |
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 |
breast cancer healthy, no evidence of disease |
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 |
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 |