Radiologic Evaluation and Breast Density (READ)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Cessation of Hormone Replacement Therapy	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1500 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Double
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
Study Start Date :	November 2004
Estimated Study Completion Date :	November 2006

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Mammogram recall for additional imaging
2. Mammographic breast density

Secondary Outcome Measures :

1. HRT cessation post study
2. Menopausal symptoms
3. Adverse events

Eligibility Criteria

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Ages Eligible for Study:	45 Years to 80 Years (Adult, Senior)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Kaiser Permanente

Investigators

Principal Investigator:	Diana SM Buist, Ph.D.	Kaiser Permanente

More Information

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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
First Posted:	July 8, 2005
Last Update Posted:	September 14, 2009
Last Verified:	September 2009

Keywords provided by Kaiser Permanente:

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; Physiological Effects of Drugs