A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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 1.4 Determine the effects of Polyphenon E on expression levels of other proteins involved in motility and invasion such as Rho GTPases and extracellular proteinases in patients with breast cancer 1.5 Determine the effects of Polyphenon E on markers of angiogenesis in patients with breast cancer 1.6 Determine the effects of Polyphenon E on other serum markers: C-reactive protein (CRP), Insulin-Like Growth factor I (IGF-I), Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) and Hepatocyte Growth Factor HGF 1.7 Evaluate the safety and tolerability of Polyphenon E in this subject population

Official Title
-----------------
Phase II Clinical Trial to Determine if Polyphenon E Inhibits c-Met Signaling and Activation of Pathways Contributing to Breast Cancer Progression

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Polyphenon E


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 1. Age ≥ 21 years and less than 75 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polyphenon E<br>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. | Drug: Polyphenon E<br>* Four 200mg capsules daily taken with a meal, for the duration of the study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum VEGF in Breast Cancer | Change in serum VEGF from baseline to post treatment with polyphenon E. | Baseline and 4 to 6 weeks | 
| Change in Serum HGF and Breast Cancer | Change in serum HGF from baseline to post Polyphenol E treatment. | Baseline and 4 to 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, EGCG, Polyphenon E, c-Met, VEGF, HGF