Radiologic Evaluation and Breast Density (READ)

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: temporary discontinuation of hormone therapy for 1 month; Other: temporary discontinuation of hormone therapy for 2 months

• Registration Number: NCT00117663
• Lead Sponsor: Kaiser Permanente

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.

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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-08
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Results First Submitted: 2016-02-03
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-28
• Last Update Submitted: 2024-03-28
• Results First Posted: 2024-04-04
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1704

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 month hormone suspension	temporary discontinuation of hormone therapy for 1 month	discontinuation of hormone therapy for 1 month prior to screening mammogram.
2 month hormone suspension	temporary discontinuation of hormone therapy for 2 months	discontinuation of hormone therapy for 2 months prior to screening mammogram.

Primary Outcome Measures

Name	Time	Method
Mammogram Recall for Additional Imaging	4 years	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.
Mammographic Breast Density	4 years	Breast density (Mean, SE) and Change in Breast density by Randomization Group

Trial Locations

Locations (1)

Group Health Research Institute; 🇺🇸 Seattle, Washington, United States