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Radiologic Evaluation and Breast Density (READ)

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.
 
ClinicalTrials.gov Identifier: NCT00117663
Recruitment Status : Unknown
Verified September 2009 by Kaiser Permanente.
Recruitment status was:  Recruiting
First Posted : July 8, 2005
Last Update Posted : September 14, 2009
Sponsor:
Information provided by:
Kaiser Permanente

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Cessation of Hormone Replacement Therapy Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
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
Study Start Date : November 2004
Estimated Study Completion Date : November 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Mammogram recall for additional imaging
  2. Mammographic breast density

Secondary Outcome Measures :
  1. HRT cessation post study
  2. Menopausal symptoms
  3. Adverse events

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
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
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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
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Contact: Dawn Fitzgibbons, MPH 206-287-2380 fitzgibbons.d@ghc.org

Locations
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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
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Principal Investigator: Diana SM Buist, Ph.D. Kaiser Permanente
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00117663    
Other Study ID Numbers: DAMD17-03-1-0447
First Posted: July 8, 2005    Key Record Dates
Last Update Posted: September 14, 2009
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:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs