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
1 other identifier
interventional
1,704
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Nov 2004
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedResults Posted
Study results publicly available
April 4, 2024
CompletedApril 4, 2024
March 1, 2024
3 years
June 30, 2005
February 3, 2016
March 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mammogram Recall for Additional Imaging
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
Breast density (Mean, SE) and Change in Breast density by Randomization Group
4 years
Study Arms (3)
No Hormone Suspension
NO INTERVENTIONNo hormone suspension prior to screening mammogram
1 month hormone suspension
ACTIVE COMPARATORdiscontinuation of hormone therapy for 1 month prior to screening mammogram.
2 month hormone suspension
ACTIVE COMPARATORdiscontinuation of hormone therapy for 2 months prior to screening mammogram.
Interventions
temporary discontinuation of hormone replacement therapy for 1 month prior to screening mammogram.
temporary discontinuation of hormone replacement therapy for 2 months prior to screening mammogram
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Group Health Research Institute
Seattle, Washington, 98101, United States
Related Publications (4)
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.
PMID: 21813728DERIVEDNewton 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.
PMID: 20979462DERIVEDAiello 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.
PMID: 20575711DERIVEDReed 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.
PMID: 19455069DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Diana Buist PhD, Principal Investigator
- Organization
- Group Health Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Diana SM Buist, Ph.D.
Kaiser Permanente
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 8, 2005
Study Start
November 1, 2004
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
April 4, 2024
Results First Posted
April 4, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share