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 Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 40
- Locations
- 4
- Primary Endpoint
- MTD defined as the dose that causes 25% DLT assessed using NCI CTCAE version 3.0
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I (defined green tea catechin extract)
Patients receive defined green tea catechin extract PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
Intervention: quality-of-life assessment (Other)
Arm I (defined green tea catechin extract)
Patients receive defined green tea catechin extract PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
Intervention: questionnaire administration (Procedure)
Arm I (defined green tea catechin extract)
Patients receive defined green tea catechin extract PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
Intervention: laboratory biomarker analysis (Procedure)
Arm I (defined green tea catechin extract)
Patients receive defined green tea catechin extract PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
Intervention: defined green tea catechin extract (Drug)
Arm II (placebo)
Patients receive placebo PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
Intervention: placebo (Other)
Arm II (placebo)
Patients receive placebo PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
Intervention: quality-of-life assessment (Other)
Arm II (placebo)
Patients receive placebo PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
Intervention: questionnaire administration (Procedure)
Arm II (placebo)
Patients receive placebo PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
Intervention: laboratory biomarker analysis (Procedure)
Outcomes
Primary Outcomes
MTD defined as the dose that causes 25% DLT assessed using NCI CTCAE version 3.0
Time Frame: 6 months
Secondary Outcomes
- Quantitative mammographic breast density(Up to 6 months)
- COMT genotype(Up to 6 months)
- Quality-of-life measures assessed using SF-36(Up to 6 months)
- Protein expression levels in benign breast tissue (Ki-67, p53, EGFR, HER2/neu, cleaved caspase-3, and ER)(Up to 6 months)
- Serum CRP levels(Up to 6 months)
- Breast tissue histology (nonproliferative, proliferative without atypia, atypical hyperplasia)(Up to 6 months)
- Hormone metabolite levels (estradiol, testosterone, IGF-1, IGFBP-3, SHBG)(Up to 6 months)
- Eicosanoid levels (urine PGE-M)(Up to 6 months)
- Levels of oxidative damage biomarkers (urine 8-OHdG, isoprostane)(Up to 6 months)