Radiologic Evaluation and Breast Density (READ)

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117663
• Other study ID #: DAMD17-03-1-0447
• Status: Completed
• Phase: N/A
• Start date: November 2004
• Est. completion date: November 2007

Study information

• Verified date: March 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1704
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• temporary discontinuation of hormone therapy for 1 month
temporary discontinuation of hormone replacement therapy for 1 month prior to screening mammogram.
• temporary discontinuation of hormone therapy for 2 months
temporary discontinuation of hormone replacement therapy for 2 months prior to screening mammogram

Locations

Country	Name	City	State
United States	Group Health Research Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mammogram Recall for Additional Imaging	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.	4 years
Primary	Mammographic Breast Density	Breast density (Mean, SE) and Change in Breast density by Randomization Group	4 years

External Links

•   Link for patients