Seattle, Washington 98101


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00117663


Primary Contact:

Principal Investigator
Diana SM Buist, Ph.D.
Group Health Cooperative

Dawn Fitzgibbons, MPH
Phone: 206-287-2380
Email: fitzgibbons.d@ghc.org


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98101
United States

Linda Palmer, RN
Phone: 206-287-2732
Email: palmer.l@ghc.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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