Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of breast cancer.

PURPOSE: This phase II trial is studying how well green tea extract works in preventing breast cancer compared to a placebo in postmenopausal women with high breast density.

The investigators have hypothesized that green tea consumption reduces breast cancer risk, and this effect is seen primarily in women who have the low-activity COMT genotype. The investigators will test this by evaluating the effects of green tea extract on breast cancer biomarkers including mammographic density, plasma insulin-like growth factor 1 (IGF-1), IGF binding protein 3 (IGFBP-3), estrone, estradiol, androstenedione, sex hormone binding globulin (SHBG), urinary estrogen metabolites and plasma F2-isoprostanes.

Further Study Information

OBJECTIVES:

1. Primary:

1.1 To determine the effects of green tea extract consumption (containing 800 mg EGCG per day) for 12 months on the following recognized biomarkers of breast cancer risk:

1. Mammographic density

2. Circulating concentrations of insulin-like growth factor 1 (IGF-1) and IGF binding protein 3 (IGFBP-3)

3. Circulating concentrations of reproductive hormones (estrone, estradiol, androstenedione) and sex hormone binding globulin (SHBG)

1.2 To determine the effects of COMT genotype on the green tea extract effects described above.

2. Secondary:

2.1 To determine the effects of green tea extract consumption (containing 800 mg EGCG per day) for 12 months on the following hypothesized biomarkers of breast cancer risk:

1. Urinary estrogen metabolites (estrone, estradiol, and their 2-hydroxy, 4-hydroxy, 2-methoxy, and 4-methoxy metabolites, estriol, and 16- hydroxyestrone)

2. Circulating concentrations of F-2 isoprostanes, a recognized biomarker of systemic oxidative stress

2.2 To determine the effects of COMT genotype on the green tea extract effects described above.

2.3 To determine the effects of COMT genotype on catechin metabolism and excretion, as measured by circulating and urinary concentrations.

Eligibility Criteria

Inclusion Criteria:

• Signed informed consent

• Healthy postmenopausal women aged 50-70 years

• "Heterogeneously dense" (51-75% glandular) or "extremely dense" (>75%glandular) breasts

• Willing to avoid consumption of green tea for 1 year

Exclusion Criteria:

• Positive serological markers of hepatitis B or hepatitis C infections

• Elevated levels of liver enzymes

• Recent (within 6 mo) or current hormone or hormone modification therapy, including systemic hormone replacement therapy, SERMS and aromatase inhibitors

• Current smoker of cigarettes or other tobacco products

• BMI <19 or >40 kg/m2

• Weight change > 10 lbs during the previous year

• History of breast cancer or proliferative breast disease

• Regular consumption of > 7 alcoholic drinks/wk

• Regular consumption of green tea (>1 cup/wk)

• Recent (within 6 mo) or current use of chemopreventive agents such as tamoxifen, raloxifene or aromatase inhibitors

• Participation in any weight loss or weight gain studies

• Currently taking Methotrexate or Enbrel

• History of ovarian cancer

• Any form of cancer in the last 5 years

• Presence of implants

Trial Contact Information

Trial Lead Organizations/Sponsors

Masonic Cancer Center at University of Minnesota

Mindy Kurzer

Principal Investigator

Hamed Samavat, BSc		Ph: 612-624-3412
		Email: samav005@umn.edu

U.S.A.
Minnesota
	Edina
	Fairview Southdale Breast Center
	Maple Grove
	Fairview Maple Grove Breast Center
	Minneapolis
	Masonic Cancer Center at University of Minnesota
		Mindy S Kurzer, Ph.D	Principal Investigator
	St. Louis Park
	Park Nicollet Cancer Center
		Julia Nissen	Ph: 952-993-3973
			Email: julia.nissen@parknicollet.com
	St. Paul
	Department of Food Science and Nutrition at the University of Minnesota
		Mindy S Kurzer, Ph.D	Ph: 612-624-9789
			Email: mkurzer@umn.edu
		Hamed Samavat, B.Sc	Ph: 612-624-3412 Ext.3
			Email: samav005@umn.edu
		Mindy S Kurzer, Ph.D	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00917735
Information obtained from ClinicalTrials.gov on March 26, 2012

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