Radiologic Evaluation and Breast Density (READ)
Basic Trial Information Trial Description Summary Further Trial Information Eligibility Criteria Trial Contact Information
Basic Trial Information
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Protocol IDs
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No phase specified
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Screening
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Active
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45 to 80
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Other
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DAMD17-03-1-0447 NCT00117663
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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
- 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)
- History of breast implants
- Breast reduction since last mammogram
- 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 |
Trial Sites
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U.S.A. |
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Washington |
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Seattle |
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| | | | | | | | Group Health Central Hospital |
| | Linda Palmer, RN |
Ph: 206-287-2732 |
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Email:
palmer.l@ghc.org 5 |
| | Diana SM Buist, Ph.D. | Principal Investigator |
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Link to the current ClinicalTrials.gov record. 6
NLM Identifer NCT00117663 Information obtained from ClinicalTrials.gov on May 27, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
Table of Links
1 | http://www.cancer.gov/clinicaltrials/learning |
2 | http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials |
3 | http://www.cancer.gov/clinicaltrials/learning/questions-to-ask-about-participat ing |
4 | http://www.nlm.nih.gov/medlineplus/druginformation.html |
5 |
mailto:palmer.l@ghc.org?Subject=NCT00117663,DAMD17-03-1-0 447:- Radiologic Evaluation and Breast Density (READ) |
6 | http://clinicaltrials.gov/show/NCT00117663 |
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