Radiologic Evaluation and Breast Density (READ)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1704 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Changes in Breast Density and Blood Hormone Levels in Postmenopausal Women Receiving Anastrozole or Exemestane for Breast Cancer

NCT00516698

Breast Cancer

COMPLETED

Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors

NCT01196936

Breast Cancer

ACTIVE_NOT_RECRUITING PHASE2

Effect of Aromatase Inhibitors on Breast Magnetic Resonance Imaging (MRI)

NCT01129622

Breast Cancer

COMPLETED PHASE2

Individuals on Hormone Therapy Breast Cancer Screening Pilot

NCT06383026

Breast Cancer

RECRUITING

Trial of 4-Hydroxytamoxifen (4-OHT) Gel in Women Aimed at Reducing Dense Breast Tissue

NCT03199963

Mammographic Breast Density

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No Hormone Suspension

No hormone suspension prior to screening mammogram

Group Type NO_INTERVENTION

No interventions assigned to this group

1 month hormone suspension

discontinuation of hormone therapy for 1 month prior to screening mammogram.

Group Type ACTIVE_COMPARATOR

temporary discontinuation of hormone therapy for 1 month

Intervention Type OTHER

temporary discontinuation of hormone replacement therapy for 1 month prior to screening mammogram.

2 month hormone suspension

discontinuation of hormone therapy for 2 months prior to screening mammogram.

Group Type ACTIVE_COMPARATOR

temporary discontinuation of hormone therapy for 2 months

Intervention Type OTHER

temporary discontinuation of hormone replacement therapy for 2 months prior to screening mammogram

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

temporary discontinuation of hormone therapy for 1 month

temporary discontinuation of hormone replacement therapy for 1 month prior to screening mammogram.

Intervention Type OTHER

temporary discontinuation of hormone therapy for 2 months

temporary discontinuation of hormone replacement therapy for 2 months prior to screening mammogram

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes