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

Alternate Title

Phase II Randomized Pilot Study of Letrozole in Postmenopausal Women at Increased Risk For Breast Cancer Based on Elevated Estradiol Levels

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Prevention Active 35 and over NCI DFCI-00024 UCLA-0210012-02, NCT00090857

Special Category: SPORE trial

Trial Description

Purpose:

Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Letrozole may be effective in preventing the development or recurrence of breast cancer in postmenopausal women who are at increased risk of developing breast cancer because of elevated estradiol levels.

This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women with elevated estradiol levels.

Eligibility:

Eligibility criteria include the following:

• At least 35 years old
• No evidence of cancer
• More than 1 month since hormone therapy
• More than 2 months since tamoxifen
• No previous bilateral mastectomy
• 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 be randomly assigned to one of two groups.

Patients in group one will receive letrozole by mouth once a day.

Patients in group two will receive a placebo by mouth once a day.

Treatment in both groups may continue for up to 1 year. All patients may then receive letrozole by mouth once a day for up to 5 years. Quality of life will be assessed periodically for 1 year.

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

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Judy Garber, MD, Principal investigator		Ph: 617-632-2282; 866-790-4500 Email: judy_garber@dfci.harvard.edu

Jonsson Comprehensive Cancer Center at UCLA

Patricia Ganz, MD, Principal investigator		Ph: 310-206-1404; 888-798-0719 Email: pganz@ucla.edu

U.S.A.
Massachusetts
	Boston
	Beth Israel Deaconess Medical Center
		Clinical Trials Office - Beth Israel Deaconess Medical Center	Ph:  617-667-9925
	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
		Clinical Trials Office - Dana-Farber/Harvard Cancer Center	Ph:  617-582-8480
	Massachusetts General Hospital
		Clinical Trials Office - Massachusetts General Hospital	Ph:  877-726-5130
Pennsylvania
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Clinical Trials Office - Abramson Cancer Center of the University of Pennsylvania	Ph:  800-474-9892
Texas
	Houston
	Dan L. Duncan Cancer Center at Baylor College of Medicine
		Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor College of Medicine	Ph:  713-798-1297

Registry Information
Official Title		A Pilot Study of Aromatase Inhibitors for Women at Increased Risk of Breast Cancer Based on Estradiol Levels
Trial Start Date		2000-09-23
Registered in ClinicalTrials.gov		NCT00090857
Date Submitted to PDQ		2004-06-10
Information Last Verified		2007-10-07
NCI Grant/Contract Number		CA06516, CA89393