A Population-Based Randomized Trial to Assess the Effects of Short-Term Cessation of Hormone Replacement Therapy on Mammography Assessments and Breast Density
Abstract
This randomized controlled trial is designed to test whether short-term (1-2 months) hormone replacement therapy (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 HRT cessation. The study is being conducted at Group Health, a managed health care organization with an organized breast cancer screening program. We project recruiting about 1,500 women who will be randomized 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 measuring breast density using a computer assisted method and mammography recall rates from an expert radiologist review of the mammograms; both readers will be blinded to HRT status. Recruitment started 11/2004; through 5/16/2007, we have contacted 5,435 potentially eligible women. Among those, 36% have agreed, 38% have refused and 25% have been ineligible. Among women who have agreed to participate, 29% have withdrawn from the study. We will continue to recruit women through August 2007.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jun 01, 2007
- Accession Number
- ADA484560
Entities
People
- Diana S. Buist
- Katherine Newton
- Susan Reed
Organizations
- Group Health Cooperative