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Epigallocatechin gallate

Epigallocatechin

Catechin

Epicatechin

Catechol

Green tea extract capsules containing 80.7 % total catechins (51.7 % EGCG)

Placebo capsules containing 50% maltodextrin, 49.5 % cellulose, and 0.5 % magnesium stearate

Two green tea extract capsules twice daily after breakfast and dinner for one year

Green tea extract supplement

Two placebo capsules twice daily after breakfast and dinner for one year

Placebo

Mindy S Kurzer, Ph.D

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.

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.

Green Tea and Reduction of Breast Cancer Risk

Phase II, Randomized,Double-blind, Placebo-controlled, Study of the Efficacy of Green Tea Extract on Biomarkers of Breast Cancer Risk in High Risk Women With Differing Catechol-O-methyl Transferase (COMT) Genotypes

Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.

Circulating levels of reproductive hormones including estrone, estradiol, androstenedione, testosterone and SHBG were measured in fasting blood samples by liquid chromatography/tandem mass spectrometry method.

Circulating levels of IGF-1 and IGFBP-3 were measured in fasting blood samples by ELISA method.

National Cancer Institute (NCI)

University of Minnesota

Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.

Green Tea Extract

Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.

Sugar Pill

Green tea extract supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year

Placebo: Two placebo capsules twice daily after breakfast and dinner for one year

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Height

Weight

Waist-to-hip ratio

We had limited success in recruiting minority populations.

Dr. Mindy Kurzer

Percent mammographic density at baseline

Percent mammographic density at month 12

Mammographic density at baseline and month 12

Mammographic Density

Circulating estrone at baseline

Circulating estrone at month 12

Circulating estradiol at baseline

Circulating estradiol at month 12

Circulating androstenedione at baseline

Circulating androstenedione at month 12

Circulating testosterone at baseline

Circulating testosterone at month 12

Circulating SHBG at baseline

Circulating SHBG at month 12

Circulating concentrations of reproductive hormones including estrone, estradiol, androstenedione, testosterone, sex hormone binding globulin (SHBG) at baseline and month 12

Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)

Circulating IGF-1 at baseline

Circulating IGF-1 at month 12

Circulating IGFBP-3 at baseline

Circulating IGFBP-3 at month 12

Circulating concentrations of IGF axis proteins including insulin-like growth factor (IGF-1) and IGF binding protein 3 (IGFBP-3) at baseline and month 12

Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3

Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of epigallocatechin gallate (EGCG).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Green Tea and Reduction of Breast Cancer Risk	NCT00917735	Breast Cancer	Green tea extra... Placebo	50 Years - 70 Years	University of Minnesota
Green Tea and Reduction of Breast Cancer Risk	NCT00917735	Breast Cancer	Green tea extra... Placebo	50 Years - 70 Years	University of Minnesota

Spots Global Cancer Trial Database for igf axis proteins