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| Sponsor: | Group Health Cooperative |
|---|---|
| Information provided by: | Group Health Cooperative |
| ClinicalTrials.gov Identifier: | NCT00117663 |
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: | Diagnostic, Randomized, Double-Blind, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 1500 |
| Study Start Date: | November 2004 |
| Estimated Study Completion Date: | November 2006 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Dawn Fitzgibbons, MPH | 206-287-2380 | fitzgibbons.d@ghc.org |
| 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. | |
| Principal Investigator: | Diana SM Buist, Ph.D. | Group Health Cooperative |
More Information
| Study ID Numbers: | DAMD17-03-1-0447 |
| Study First Received: | June 30, 2005 |
| Last Updated: | September 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00117663 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Randomized controlled trial Mammography health care setting hormone replacement therapy |
breast density mammography performance Breast Carcinoma |
|
Neoplasms Neoplasms by Site Skin Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Breast Neoplasms Hormones Pharmacologic Actions Breast Diseases |