Radiologic Evaluation and Breast Density (READ)

Kaiser Permanente

Status: Completed

Conditions: Breast Cancer

Treatments: Other: temporary discontinuation of hormone therapy for 1 month; Other: temporary discontinuation of hormone therapy for 2 months

Study type: Interventional

Funder types: Other

Identifiers

NCT00117663

DAMD17-03-1-0447

Details and patient eligibility

About

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.

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.

Enrollment: 1,704 patients

Sex: Female

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,704 participants in 3 patient groups

No Hormone Suspension

No Intervention group

Description:

No hormone suspension prior to screening mammogram

1 month hormone suspension

Active Comparator group

Description:

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

Treatment:

Other: temporary discontinuation of hormone therapy for 1 month

2 month hormone suspension

Active Comparator group

Description:

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

Treatment:

Other: temporary discontinuation of hormone therapy for 2 months