The Effect of Aspirin on Mammogram Density (TEAM)
- 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
- 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
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
PROJECTED ACCRUAL: A total of 144 participants will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Comparison of the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density
Baseline and end-of-study (6 month timepoint)
Nicole Urban, ScD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|