The purpose of this study is to determine whether cessation of hormone replacement therapy for one or two months before a screening mammogram will improve its performance by decreasing breast density.
This randomized, controlled trial is designed to test whether short-term (1-2 months) HRT cessation will sufficiently lower breast density to decrease the proportion of women who receive a recommendation for additional evaluation following a screening mammogram, and to examine whether there is a trend by duration of cessation. The study is being conducted at Group Health Cooperative, a managed health care organization in western Washington State with an organized breast cancer screening program. We are recruiting 1,500 women and will randomize women to one of three HRT arms: 1) cessation two months before the screening mammogram; 2) cessation one month before; and 3) continued HRT use. We are using a computer-assisted method to measure mammographic breast density continuously. Mammography recall rates are being determined from an expert radiologist review of the mammograms, blinded to HRT status.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
1,704
temporary discontinuation of hormone replacement therapy for 1 month prior to screening mammogram.
temporary discontinuation of hormone replacement therapy for 2 months prior to screening mammogram
Group Health Research Institute
Seattle, Washington, United States
Mammogram Recall for Additional Imaging
Mammography recall was defined as any assessment requiring additional imaging or evaluation of either breast (BI-RADS assessment of 0 for either or both breasts)(30) determined exclusively from the study radiologists' interpretation.
Time frame: 4 years
Mammographic Breast Density
Breast density (Mean, SE) and Change in Breast density by Randomization Group
Time frame: 4 years
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