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.

Condition	Intervention
Breast Cancer	Drug: Cessation of Hormone Replacement Therapy

Further Study Details: 

Primary Outcomes: Mammogram recall for additional imaging; Mammographic breast density
Secondary Outcomes: HRT cessation post study; Menopausal symptoms; Adverse events
Expected Total Enrollment:  1500

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.

Ages Eligible for Study:  45 Years   -   80 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00117663

Diana Buist, Ph.D.      206-287-2931    buist.d@ghc.org
Linda Palmer, RN      206-287-2732    palmer.l@ghc.org

Washington
      Group Health Cooperative Center for Health Studies, Seattle,  Washington,  98101,  United States; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  DAMD17-03-1-0447
Record last reviewed:  June 2005
Last Updated:  July 25, 2005
Record first received:  July 7, 2005
ClinicalTrials.gov Identifier:  NCT00117663
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26