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


N/A
45 Years
80 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Outcome Measure:

Mammogram recall for additional imaging

Principal Investigator

Diana SM Buist, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Group Health Cooperative

Authority:

United States: Institutional Review Board

Study ID:

DAMD17-03-1-0447

NCT ID:

NCT00117663

Start Date:

November 2004

Completion Date:

November 2006

Related Keywords:

  • Breast Cancer
  • Randomized controlled trial
  • Mammography
  • health care setting
  • hormone replacement therapy
  • breast density
  • mammography performance
  • Breast Carcinoma
  • Breast Neoplasms

Name

Location

Group Health Research InstituteSeattle, Washington  98101