Radiologic Evaluation and Breast Density (READ)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by Group Health Cooperative.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Group Health Cooperative

ClinicalTrials.gov Identifier:

NCT00117663

First received: June 30, 2005

Last updated: September 10, 2009

Last verified: September 2009

History of Changes

Purpose

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.

Condition	Intervention
Breast Cancer	Drug: Cessation of Hormone Replacement Therapy


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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Hormone Replacement Therapy Hormones Mammography

U.S. FDA Resources

Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:

Mammogram recall for additional imaging
Mammographic breast density

Secondary Outcome Measures:

HRT cessation post study
Menopausal symptoms
Adverse events


Estimated Enrollment:	1500
Study Start Date:	November 2004
Estimated Study Completion Date:	November 2006

Detailed 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.

Eligibility


Ages Eligible for Study:	45 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117663

Contacts


Contact: Dawn Fitzgibbons, MPH	206-287-2380	fitzgibbons.d@ghc.org

Locations


United States, Washington
Group Health Research Institute	Recruiting
Seattle, Washington, United States, 98101
Contact: Linda Palmer, RN 206-287-2732 palmer.l@ghc.org
Principal Investigator: Diana SM Buist, Ph.D.

Sponsors and Collaborators

Group Health Cooperative

Investigators


Principal Investigator:	Diana SM Buist, Ph.D.	Group Health Cooperative

More Information

No publications provided by Group Health Cooperative

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lowry SJ, Aiello Bowles EJ, Anderson ML, Buist DS. Predictors of breast density change after hormone therapy cessation: results from a randomized trial. Cancer Epidemiol Biomarkers Prev. 2011 Oct;20(10):2309-12. doi: 10.1158/1055-9965.EPI-11-0629. Epub 2011 Aug 3.

Newton KM, Anderson ML, Reed SD, Bowles EJ, Buist DS. Factors associated with non-compliance with hormone therapy cessation before screening mammography. Climacteric. 2011 Apr;14(2):268-74. doi: 10.3109/13697137.2010.520172. Epub 2010 Oct 27.

Aiello Bowles EJ, Anderson ML, Reed SD, Newton KM, Fitzgibbons ED, Seger D, Buist DS. Mammographic breast density and tolerance for short-term postmenopausal hormone therapy suspension. J Womens Health (Larchmt). 2010 Aug;19(8):1467-74. doi: 10.1089/jwh.2009.1681.

Reed SD, Buist DS, Anderson ML, Bowles EJ, Fitzgibbons D, Seger D, Newton KM. Short-term (1-2 mo) hormone therapy cessation before mammography. Menopause. 2009 Nov-Dec;16(6):1125-31. doi: 10.1097/gme.0b013e3181a5ce60.


ClinicalTrials.gov Identifier:	NCT00117663 History of Changes
Other Study ID Numbers:	DAMD17-03-1-0447
Study First Received:	June 30, 2005
Last Updated:	September 10, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Group Health Cooperative:


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

Additional relevant MeSH terms:


Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015

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