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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Screening Active 45 to 80 Other DAMD17-03-1-0447 NCT00117663

Trial Description

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.

Further Study Information

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Group Health Central Hospital

Diana SM Buist, Ph.D.

Principal Investigator

Diana Buist, Ph.D.		Ph: 206-287-2931
		Email: buist.d@ghc.org

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

U.S.A.
Washington
	Seattle
	Group Health Central Hospital
		Linda Palmer, RN	Ph: 206-287-2732
			Email: palmer.l@ghc.org
		Diana SM Buist, Ph.D.	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00117663
Information obtained from ClinicalTrials.gov on May 27, 2008