Breast Cancer Clinical Trial
Radiologic Evaluation and Breast Density (READ)
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
1 or more prior screening mammograms at Group Health Cooperative within the past 2 years
Currently taking HRT
Taking HRT at prior screening mammogram
Due for a screening mammogram
Exclusion Criteria:
BI-RADS breast density of 1 (entirely fat)
Previous cardiovascular events (heart surgery, catheterization, stent bypass, angioplasty, stroke, DVT)
Previous breast cancer
History of breast implants
Breast reduction since last mammogram
Mastectomy
History of using Tamoxifen or Raloxifene
Declined contact or use of data for research
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There is 1 Location for this study
Seattle Washington, 98101, United States More Info
Principal Investigator
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