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

Alternate Title

Phase I Pilot Chemoprevention Study of IH636 Grape Seed Proanthocyanidin Extract in Healthy Postmenopausal Women at High Risk of Developing Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Prevention	Active	40 to 75	NCI	CHNMC-IRB-03178 NCT00100893

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 IH636 grape seed extract may prevent breast cancer.

This phase I trial is studying the side effects and best dose of IH636 grape seed extract in preventing breast cancer in postmenopausal women at risk of developing breast cancer.

Eligibility:

Eligibility criteria include the following:

• 40-75 years old
• No previous ductal carcinoma in situ
• More than 3 months since hormone therapy
• 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 placebo by mouth once or twice a day for 2 weeks. They will then receive IH636 grape seed extract by mouth once or twice a day for up to 3 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

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

Registry Information
Official Title		A Phase I Prevention Trial of ACTIVINTM Grape Seed Extract as an Aromatase Inhibitor In Healthy Postmenopausal Women at Risk for Breast Cancer
Trial Start Date		2005-01-14
Trial Completion Date		2008-05-30 (estimated)
Registered in ClinicalTrials.gov		NCT00100893
Date Submitted to PDQ		2004-11-18
Information Last Verified		2007-04-06
NCI Grant/Contract Number		CA33572