- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00470561
Effect of Aspirin on Mammogram Density in Healthy Postmenopausal Women With a Moderate or High Level of Breast Density
The Effect of Aspirin on Mammogram Density (TEAM)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109-1024
- Fred Hutchinson Cancer Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Two placebo pills per day for 6 months
Other Names:
|
Active Comparator: Aspirin
|
Two 325 mg doses of aspirin per day for 6 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density
Time Frame: Baseline and end-of-study (6 month timepoint)
|
Baseline and end-of-study (6 month timepoint)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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)
|
Adverse events
Time Frame: Collected over the course of tehestudy
|
Collected over the course of tehestudy
|
|
Putative biomarkers of breast and ovarian cancer
Time Frame: Baseline and end-of-study (6 month timepoint)
|
Baseline and end-of-study (6 month timepoint)
|
|
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
|
Baseline and 6 month timepoints
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Nicole Urban, ScD, Fred Hutchinson Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- PHS 1908.00
- FHCRC-PHS-1908.00
- FHCRC-1908
- CDR0000544639 (Registry Identifier: PDQ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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