Radiologic Evaluation and Breast Density (READ)
March 28, 2024 updated by: Kaiser Permanente
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
1704
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98101
- Group Health Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No Hormone Suspension
No hormone suspension prior to screening mammogram
|
|
|
Active Comparator: 1 month hormone suspension
discontinuation of hormone therapy for 1 month prior to screening mammogram.
|
temporary discontinuation of hormone replacement therapy for 1 month prior to screening mammogram.
|
|
Active Comparator: 2 month hormone suspension
discontinuation of hormone therapy for 2 months prior to screening mammogram.
|
temporary discontinuation of hormone replacement therapy for 2 months prior to screening mammogram
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mammogram Recall for Additional Imaging
Time Frame: 4 years
|
Mammography recall was defined as any assessment requiring additional imaging or evaluation of either breast (BI-RADS assessment of 0 for either or both breasts)(30) determined exclusively from the study radiologists' interpretation.
|
4 years
|
|
Mammographic Breast Density
Time Frame: 4 years
|
Breast density (Mean, SE) and Change in Breast density by Randomization Group
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Adverse events
|
|
Menopausal symptoms
|
|
HRT cessation post study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Diana SM Buist, Ph.D., Kaiser Permanente
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lowry SJ, Aiello Bowles EJ, Anderson ML, Buist DS. Predictors of breast density change after hormone therapy cessation: results from a randomized trial. Cancer Epidemiol Biomarkers Prev. 2011 Oct;20(10):2309-12. doi: 10.1158/1055-9965.EPI-11-0629. Epub 2011 Aug 3.
- Newton KM, Anderson ML, Reed SD, Bowles EJ, Buist DS. Factors associated with non-compliance with hormone therapy cessation before screening mammography. Climacteric. 2011 Apr;14(2):268-74. doi: 10.3109/13697137.2010.520172. Epub 2010 Oct 27.
- Aiello Bowles EJ, Anderson ML, Reed SD, Newton KM, Fitzgibbons ED, Seger D, Buist DS. Mammographic breast density and tolerance for short-term postmenopausal hormone therapy suspension. J Womens Health (Larchmt). 2010 Aug;19(8):1467-74. doi: 10.1089/jwh.2009.1681.
- Reed SD, Buist DS, Anderson ML, Bowles EJ, Fitzgibbons D, Seger D, Newton KM. Short-term (1-2 mo) hormone therapy cessation before mammography. Menopause. 2009 Nov-Dec;16(6):1125-31. doi: 10.1097/gme.0b013e3181a5ce60.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
June 30, 2005
First Submitted That Met QC Criteria
June 30, 2005
First Posted (Estimated)
July 8, 2005
Study Record Updates
Last Update Posted (Actual)
April 4, 2024
Last Update Submitted That Met QC Criteria
March 28, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAMD17-03-1-0447
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.