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Radiologic Evaluation and Breast Density (READ)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Group Health Cooperative.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00117663
First received: June 30, 2005
Last updated: September 10, 2009
Last verified: September 2009
History of Changes

June 30, 2005
September 10, 2009
November 2004
Not Provided
  • Mammogram recall for additional imaging
  • Mammographic breast density
Same as current
Complete list of historical versions of study NCT00117663 on ClinicalTrials.gov Archive Site
  • HRT cessation post study
  • Menopausal symptoms
  • Adverse events
Same as current
Not Provided
Not Provided
 
Radiologic Evaluation and Breast Density (READ)
A Population-Based Randomized Trial to Assess the Effects of Short-Term Cessation of Hormone Replacement Therapy (HRT) on Mammography Assessments and Breast Density

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Breast Cancer
Drug: Cessation of Hormone Replacement Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
November 2006
Not Provided

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
Female
45 Years to 80 Years
Yes
Contact: Dawn Fitzgibbons, MPH 206-287-2380 fitzgibbons.d@ghc.org
United States
 
NCT00117663
DAMD17-03-1-0447
Not Provided
Not Provided
Group Health Cooperative
Not Provided
Principal Investigator: Diana SM Buist, Ph.D. Group Health Cooperative
Group Health Cooperative
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP