NCT00516243

Defined Green Tea Catechin Extract in Treating Women With Hormone Receptor Negative Stage I-III Breast Cancer

Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women With a History of Hormone Receptor-Negative Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase I trial studies the side effects and best dose of defined green tea catechin extract in treating women with hormone receptor-negative stage I-III breast cancer. Green tea extract contains ingredients that may prevent or slow the growth of breast cancer.

Detailed description

PRIMARY OBJECTIVES: I. Demonstrate the safety of green tea catechin extract (Polyphenon E) in women with a history of hormone receptor-negative breast cancer. II. Determine the maximum tolerated dose of Polyphenon E in women with a history of hormone receptor-negative breast cancer. SECONDARY OBJECTIVES: I. Determine the efficacy of Polyphenon E in modulating histologic changes (nonproliferative, proliferative without atypia, atypical hyperplasia) on core biopsy of the contralateral breast. II. Determine the efficacy of Polyphenon E in modulating immunohistochemical expression of Ki-67 (proliferation index), p53, EGFR, HER2/neu, cleaved caspase-3 (apoptosis marker), and estrogen receptor on core biopsy tissue of the contralateral breast. III. Determine the efficacy of Polyphenon E in modulating mammographic breast density of the contralateral breast. IV. Determine the efficacy of Polyphenon E in modulating hormone metabolites (serum estradiol, testosterone, IGF-1, IGFBP-3, SHBG). V. Determine the efficacy of Polyphenon E in modulating eicosanoid levels (urine PGE-M). VI. Determine the efficacy of Polyphenon E in modulating biomarkers of oxidative damage (urine 8-OHdG, isoprostane). VII. Determine the efficacy of Polyphenon E in modulating serum C-reactive protein. VIII. Determine the activity of Polyphenon E in relation to COMT genotype. IX. Assess quality of life and attitudes toward complementary and alternative medicine in women with a history of breast cancer. OUTLINE: This is a dose-escalation study. Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive defined green tea catechin extract orally (PO) twice daily (BID) for 6 months in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO BID for 6 months in the absence of disease progression or unacceptable toxicity. Patients undergo a core biopsy and mammogram of the contralateral breast at baseline and after 6 months for histological evaluation, IHC analysis, and mammographic density reading. Core biopsy tissue is assessed for proliferative changes and presence of atypia using standardized histological criteria. Core biopsy tissue is also analyzed by IHC for the following proteins: Ki-67 (proliferation index), p53, EGFR, HER2/neu, cleaved caspase-3 (apoptosis marker), and estrogen receptor (ER). Blood and urine samples are collected at baseline and every 2 months during treatment to measure drug effect biomarkers: serum estradiol, testosterone, insulin-like growth factor-1 (IGF-1), IGF binding protein-3 (IGFBP-3), and sex hormone-binding globulin (SHBG) by immunological laboratory methods; urine prostaglandin levels (PGE-M) by tandem mass spectrometry; urine oxidative damage markers (8-OHdG, isoprostane) and serum C-reactive protein (CRP) by ELISA; and catechol-O-methyltransferase (COMT) genotype (at baseline only). Patients complete a questionnaire assessing quality of life (SF-36) and attitudes toward complementary and alternative medicine at baseline and at 6 months. After completion of study treatment, patients are followed for 1 month.

Conditions

• Estrogen Receptor-negative Breast Cancer
• Progesterone Receptor-negative Breast Cancer
• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer

Interventions

Type	Name	Description
OTHER	placebo	Given PO
OTHER	quality-of-life assessment	Ancillary studies
PROCEDURE	questionnaire administration	Ancillary studies
PROCEDURE	laboratory biomarker analysis	Correlative studies
DRUG	defined green tea catechin extract	Given PO

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2007-08-15
• Last updated: 2014-09-12

Locations

4 sites across 1 country: United States