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

Alternate Title

Phase II Pilot Chemoprevention Study of Deslorelin in Combination With Low-Dose Add-Back Estradiol and Testosterone in Premenopausal Women With or Without a BRCA Gene Mutation Who Are at High Risk for Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Prevention Active 21 to 48 NCI CHNMC-IRB-02164 NCT00080756

Special Category: NCI Avon award trial

Trial Description

Purpose:

Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Deslorelin combined with low- dose add-back estradiol and testosterone (given to replace hormones suppressed by deslorelin) may be effective in preventing breast cancer in at-risk women.

This phase II trial is studying how well giving deslorelin together with estradiol and testosterone works in preventing breast cancer in premenopausal women who are at high risk for this disease.

Eligibility:

Eligibility criteria include the following:

• 21-48 years old
• More than 1 year since gonadotropin-releasing hormone agonist therapy
• At least 6 months since implanted or injected forms of birth control
• 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:

Participants will receive deslorelin, estradiol, and testosterone as a nasal spray once a day for 6-10 months. Quality of life will be assessed periodically for 2 years.

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

City of Hope Comprehensive Cancer Center

Clinical Trials Office - New Patient Services		Ph: 800-826-4673 Email: becomingapatient@coh.org

U.S.A.
California
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - City of Hope Comprehensive Cancer Center	Ph:  800-826-4673
			Email: becomingapatient@coh.org
	Los Angeles
	USC/Norris Comprehensive Cancer Center and Hospital
		Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital	Ph:  323-865-0451

Registry Information
Official Title		Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers
Trial Start Date		2004-02-04
Trial Completion Date		2008-12-15 (estimated)
Registered in ClinicalTrials.gov		NCT00080756
Date Submitted to PDQ		2004-01-22
Information Last Verified		2008-12-14
NCI Grant/Contract Number		CA33572