Breast Cancer Clinical Trial

Radiologic Evaluation and Breast Density (READ)

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.

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Full 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.

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Eligibility 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

Study is for people with:

Breast Cancer

Estimated Enrollment:

1500

Study ID:

NCT00117663

Recruitment Status:

Unknown status

Sponsor:

Kaiser Permanente

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There is 1 Location for this study

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Group Health Research Institute
Seattle Washington, 98101, United States More Info
Linda Palmer, RN
Contact
206-287-2732
[email protected]
Diana SM Buist, Ph.D.
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

1500

Study ID:

NCT00117663

Recruitment Status:

Unknown status

Sponsor:


Kaiser Permanente

How clear is this clinincal trial information?

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