Phase II Clinical Trial to Determine if Polyphenon E Inhibits c-Met Signaling and Activation of Pathways Contributing to Breast Cancer Progression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in Serum VEGF in Breast Cancer
研究概览
简要总结
To see if an extract of green tea can affect certain markers of breast cancer and breast cancer progression in women with a recent biopsy positive for cancer and who are scheduled for surgery.
详细描述
To evaluate the short-term effects of a daily dose of Polyphenon E administered during the interval between breast biopsy and surgery in women with recently diagnosed breast cancer. Endpoints will be changes in serum and tissue biomarkers related to progression of cancer.
The effect of Polyphenon E on tumor cell c-Met expression and phosphorylation is the primary objective. Secondary objectives include the effects on the other tissue and serum biomarkers. Evaluation of the safety and tolerability of Polyphenon E in this subject population is another objective.
1.1 Determine the effects of Polyphenon E on tumor cell c-Met expression and phosphorylation levels in patients with breast cancer
1.2 Determine the effects of Polyphenon E on PI-3K activation in patients with breast cancer
1.3 Determine the effects of Polyphenon E on MAPK activation in patients with breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Definitive biopsy demonstrating primary breast cancer
- •Residual breast cancer requiring additional surgical resection
- •Stage I, II or III disease
- •Patient has ability to give signed informed consent
- •Normal hepatic and renal function (creatinine<1.5, transaminases <1.5 times upper limit of normal).
- •ECOG Performance status of 0 or
- •Age ≥ 21 years and less than 75
排除标准
- •Prior hormonal or surgical therapy for breast cancer
- •Abnormal liver function test
- •Liver or kidney problems that would interfere with metabolism of study drug
- •Any condition that would hamper informed consent or ability to comply with study protocol
- •Participation in another research study in the last three months
- •Known malignancy at any site other than breast
- •Recent consumption of green tea (5 or more cups per day, within one week prior to biopsy)
- •Allergy or intolerance to any component of green tea
- •Inability or refusal to comply with definitive surgical therapy
研究组 & 干预措施
Polyphenon E
This is a single arm study comparing changes within patients before and after receiving the experimental drug Polyphenon E for the duration of the study, between recruitment and surgery for breast cancer.
干预措施: Polyphenon E (Drug)
结局指标
主要结局
Change in Serum VEGF in Breast Cancer
时间窗: Baseline and 4 to 6 weeks
Change in serum VEGF from baseline to post treatment with polyphenon E.
Change in Serum HGF and Breast Cancer
时间窗: Baseline and 4 to 6 weeks
Change in serum HGF from baseline to post Polyphenol E treatment.
次要结局
未报告次要终点
研究者
Jerry McLarty
Professor
Louisiana State University Health Sciences Center Shreveport