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Radiologic Evaluation and Breast Density (READ)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Kaiser Permanente.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00117663
First Posted: July 8, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kaiser Permanente
  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.

Condition Intervention
Breast Cancer Drug: Cessation of Hormone Replacement Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: A Population-Based Randomized Trial to Assess the Effects of Short-Term Cessation of Hormone Replacement Therapy (HRT) on Mammography Assessments and Breast Density

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Mammogram recall for additional imaging
  • Mammographic breast density

Secondary Outcome Measures:
  • HRT cessation post study
  • Menopausal symptoms
  • Adverse events

Estimated Enrollment: 1500
Study Start Date: November 2004
Estimated Study Completion Date: November 2006
Detailed Description:
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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117663


Contacts
Contact: Dawn Fitzgibbons, MPH 206-287-2380 fitzgibbons.d@ghc.org

Locations
United States, Washington
Group Health Research Institute Recruiting
Seattle, Washington, United States, 98101
Contact: Linda Palmer, RN    206-287-2732    palmer.l@ghc.org   
Principal Investigator: Diana SM Buist, Ph.D.         
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Diana SM Buist, Ph.D. Kaiser Permanente
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00117663     History of Changes
Other Study ID Numbers: DAMD17-03-1-0447
First Submitted: June 30, 2005
First Posted: July 8, 2005
Last Update Posted: October 12, 2017
Last Verified: September 2009

Keywords provided by Kaiser Permanente:
Randomized controlled trial
Mammography
health care setting
hormone replacement therapy
breast density
mammography performance
Breast Carcinoma

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs