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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Study of Exemestane in Postmenopausal Women at High Risk for Invasive Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Prevention Active Postmenopausal NCI GUMC-2007-313 NCI-04-C-0044, NCT00085072, GUMC-2007-313, GT 07-313, 2007-313

Trial Description

Purpose:

High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. Exemestane may decrease estrogen levels and reduce breast density.

This phase II trial is studying how well exemestane works in preventing cancer in postmenopausal women who are at high risk of developing invasive breast cancer.

Eligibility:

Eligibility criteria include the following:

• More than 6 months since hormone therapy
• More than 2 years since anticancer treatment
• No previous aromatase inhibitors
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive exemestane by mouth once a day for up to 2 years.

Quality of life will be assessed periodically. After finishing treatment, patients will be evaluated every 6 months.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Jennifer Eng-Wong, MD, Principal investigator		Ph: 202-444-4948
Suparna Wedam, MD, Principal investigator		Ph: 301-496-3986

U.S.A.
District of Columbia
	Washington
	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
		Clinical Trials Office - Lombardi Comprehensive Cancer Center	Ph:  202-444-0381

Registry Information
Official Title		A Trial Of Exemestane Alone Or In Combination With Celecoxib In Postmenopausal Women With DCIS Or At High Risk For Invasive Breast Cancer
Trial Start Date		2004-12-09
Trial Completion Date		2011-06-30 (estimated)
Registered in ClinicalTrials.gov		NCT00085072
Date Submitted to PDQ		2004-04-14
Information Last Verified		2008-12-12