A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Phase II Clinical Trial to Determine if Polyphenon E Inhibits c-Met Signaling and Activation of Pathways Contributing to Breast Cancer Progression|
- Change in Serum VEGF in Breast Cancer [ Time Frame: Baseline and 4 to 6 weeks ] [ Designated as safety issue: No ]Change in serum VEGF from baseline to post treatment with polyphenon E.
- Change in Serum HGF and Breast Cancer [ Time Frame: Baseline and 4 to 6 weeks ] [ Designated as safety issue: No ]Change in serum HGF from baseline to post Polyphenol E treatment.
|Study Start Date:||May 2004|
|Estimated Study Completion Date:||July 2013|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: 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.
Drug: Polyphenon E
Four 200mg capsules daily taken with a meal, for the duration of the study.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676793
|United States, Louisiana|
|LSU Health Sciences Center|
|Shreveport, Louisiana, United States, 71103|
|United States, New York|
|Columbia Presbyterian Hospital|
|New York, New York, United States, 10032|
|Principal Investigator:||Gary Burton, M.D.||LSU Health Sciences Center Shreveport|