Effect of Aspirin on Mammogram Density in Healthy Postmenopausal Women With a Moderate or High Level of Breast Density
|ClinicalTrials.gov Identifier: NCT00470561|
Recruitment Status : Completed
First Posted : May 7, 2007
Last Update Posted : November 15, 2010
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 or disease||Intervention/treatment|
|Mammographic Breast Density||Drug: Aspirin Drug: Placebo|
- 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.
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Effect of Aspirin on Mammogram Density (TEAM)|
|Study Start Date :||November 2005|
|Primary Completion Date :||June 2007|
|Study Completion Date :||July 2007|
|Active Comparator: Aspirin||
Two 325 mg doses of aspirin per day for 6 months
Other Name: Acetylsalicylic acid
|Placebo Comparator: Placebo||
Two placebo pills per day for 6 months
Other Name: Placebo, sugar pill
- Comparison of the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density [ Time Frame: Baseline and end-of-study (6 month timepoint) ]
- 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
- Adverse events [ Time Frame: Collected over the course of tehestudy ]
- Putative biomarkers of breast and ovarian cancer [ Time Frame: 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470561
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Study Chair:||Nicole Urban, ScD||Fred Hutchinson Cancer Research Center|