Radiologic Evaluation and Breast Density (READ)
Conditions
Breast Cancer
Conditions: Keywords
Randomized controlled trial, Mammography, health care setting, hormone replacement therapy, breast density, mammography performance, Breast Carcinoma
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic
Intervention
Name: Cessation of Hormone Replacement Therapy
Type: Drug
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 80 Years
Minimum Age: 45 Years
Gender: Female
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
Location
Group Health Research Institute
Seattle, Washington, United States
Status: Recruiting
Contact: Linda Palmer, RN - 206-287-2732 - palmer.l@ghc.org
Start Date
November 2004
Completion Date
November 2006
Sponsors
Group Health Cooperative
Source
Group Health Cooperative
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page