Radiologic Evaluation and Breast Density (READ)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Population-Based Randomized Trial to Assess the Effects of Short-Term Cessation of Hormone Replacement Therapy (HRT) on Mammography Assessments and Breast Density

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Cessation of Hormone Replacement Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cessation of Hormone Replacement Therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mammogram recall for additional imaging |  |  | 
| Mammographic breast density |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRT cessation post study |  |  | 
| Menopausal symptoms |  |  | 
| Adverse events |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, Mammography, health care setting, hormone replacement therapy, breast density, mammography performance, Breast Carcinoma