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

Alternate Title

Phase II Chemoprevention Study of Simvastatin in Women at High Risk of Developing a New Breast Cancer After Undergoing Surgical Resection for Ductal Carcinoma in Situ or Stage I-III Invasive Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Prevention	Active	18 and over	NCI	JHOC-J0485 J0485, JHOC-SKCCC-J0485, JHOC-04100404, NCT00334542

Special Category: NCI Avon award trial

Trial Description

Purpose:

Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of simvastatin may keep cancer from coming back in women who are at high risk for a new breast cancer after undergoing surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast cancer.

This phase II trial is studying how well simvastatin works in preventing a new breast cancer in women at high risk for a new breast cancer after undergoing surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Has completed treatment for breast cancer that included surgery with or without radiation therapy, chemotherapy, and/or hormone therapy at least 3 months ago
• Has at least one healthy breast without cancer that has not undergone radiation therapy or mastectomy
• More than 3 months since hormone therapy, including hormone replacement therapy
• More than 3 months since drugs that lower cholesterol
• 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 simvastatin by mouth once a day for up to 6½ months.

Patients will undergo blood collection periodically for laboratory studies. They will also undergo breast density measurement, mammography, and quality of life assessments at the beginning of treatment and after finishing treatment.

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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Vered Stearns, MD, Principal investigator		Ph: 443-287-6489

U.S.A.
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins	Ph:  410-955-8804
			Email: jhcccro@jhmi.edu
Massachusetts
	Boston
	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
		Judy Garber, MD	Ph:  617-632-2282 866-790-4500
			Email: judy_garber@dfci.harvard.edu

Registry Information
Official Title		A Phase II Study of Simvastatin in Women at High Risk for a New Breast Cancer
Trial Start Date		2006-03-29
Trial Completion Date		2009-06-30 (estimated)
Registered in ClinicalTrials.gov		NCT00334542
Date Submitted to PDQ		2006-03-29
Information Last Verified		2009-07-05
NCI Grant/Contract Number		CA06973, CA88843

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