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

Alternate Title

Phase I Randomized Study of Green Tea Catechin Extract (Polyphenon E) in Women With a History of Hormone Receptor-Negative Stage I-III Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Biomarker/Laboratory analysis, Prevention, Treatment	Active	21 to 65	NCI	MDA-MDA04-4-01 MDA04-4-01, NCT00516243, MDA-2006-0521, CPMC-IRB-AAAB7638

Trial Description

Purpose:

Green tea extract contains ingredients that may prevent or slow the growth of breast cancer.

This randomized phase I trial is studying the side effects and best dose of green tea extract in treating women with hormone receptor -negative stage I, stage II, or stage III breast cancer.

Eligibility:

Eligibility criteria include the following:

• 21-65 years old
• No current evidence of breast cancer
• No recurrent or metastatic breast cancer
• Normal mammogram of the uninvolved breast within the past year
• No previous cancer in both breasts
• Estrogen-receptor negative and progesterone-receptor negative breast cancer
• Registered in the outpatient medical oncology clinic at Columbia University Medical Center, MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, or the Weill-Cornell campus of New York Presbyterian Hospital
• At least 6 months since chemotherapy, radiation therapy, or surgery
• No previous radiation therapy or implant to the uninvolved breast
• More than 1 month since drinking tea or taking medications, herbs, or vitamin and mineral supplements that contain tea or caffeine
• No more than three 8-oz cups of coffee per day within the past month
• 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 (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive green tea extract by mouth twice a day for up to 6 months.

Patients in group two will receive a placebo by mouth twice a day for up to 6 months.

Patients will undergo a core biopsy and mammogram of the uninvolved breast at the beginning of the study and after 6 months. They will also undergo blood and urine sample collection at the beginning of the study and every 2 months for laboratory studies.

Patients will fill out a quality-of-life questionnaire at the beginning of the study and at 6 months.

After finishing treatment, patients will be evaluated for 1 month.

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

M. D. Anderson Cancer Center at University of Texas

Scott Lippman, MD, FACP, Principal investigator		Ph: 713-745-3672

U.S.A.
New York
	New York
	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
		Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	Ph:  212-305-8615
	Memorial Sloan-Kettering Cancer Center
		Clifford Hudis, MD	Ph:  646-888-4551 800-525-2225
Texas
	Houston
	Dan L. Duncan Cancer Center at Baylor College of Medicine
		Powel Brown, MD, PhD	Ph:  713-798-8874
			Email: pbrown@breastcenter.tmc.edu
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245

Registry Information
Official Title		Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with a History of Hormone Receptor-Negative Breast Cancer
Trial Start Date		2007-06-25
Trial Completion Date		2009-01-09 (estimated)
Registered in ClinicalTrials.gov		NCT00516243
Date Submitted to PDQ		2007-07-30
Information Last Verified		2009-04-29
NCI Grant/Contract Number		CA16672