N/A
N=1,704
Radiologic Evaluation and Breast Density (READ)
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00117663 ↗Enrolled (actual)
1,704
Serious AEs
0.6%
Results posted
Apr 2024
Primary outcome: Primary: Mammogram Recall for Additional Imaging — 11.3; 12.3; 9.8 percentage of women recalled
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- temporary discontinuation of hormone therapy for 1 month (Other); temporary discontinuation of hormone therapy for 2 months (Other)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Kaiser Permanente
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mammogram Recall for Additional Imaging |
11.3; 12.3; 9.8 | — |
| PRIMARY Mammographic Breast Density |
0.1; -0.9; -1.5 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00117663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.