NCT00117663

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,704 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: Female
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	temporary discontinuation of hormone therapy for 1 month	temporary discontinuation of hormone replacement therapy for 1 month prior to screening mammogram.
OTHER	temporary discontinuation of hormone therapy for 2 months	temporary discontinuation of hormone replacement therapy for 2 months prior to screening mammogram

Timeline

• Start date: 2004-11-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2005-07-08
• Last updated: 2024-04-04
• Results posted: 2024-04-04

Locations

1 site across 1 country: United States