Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women With a History of Hormone Receptor-Negative Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- MTD defined as the dose that causes 25% DLT assessed using NCI CTCAE version 3.0
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: placebo (Other)
Arm II (placebo)
Patients receive placebo PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
干预措施: 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.
干预措施: questionnaire administration (Procedure)
Arm II (placebo)
Patients receive placebo PO BID for 6 months in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Procedure)
结局指标
主要结局
MTD defined as the dose that causes 25% DLT assessed using NCI CTCAE version 3.0
时间窗: 6 months
次要结局
- 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)