Spots Global Cancer Trial Database for A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression
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Trial Identification
Brief Title: A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression
Official Title: Phase II Clinical Trial to Determine if Polyphenon E Inhibits c-Met Signaling and Activation of Pathways Contributing to Breast Cancer Progression
Study ID: NCT00676793
Conditions
Interventions
Study Description
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
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
LSU Health Sciences Center, Shreveport, Louisiana, United States
Columbia Presbyterian Hospital, New York, New York, United States
Contact Details
Name: Gary Burton, M.D.
Affiliation: LSU Health Sciences Center Shreveport
Role: PRINCIPAL_INVESTIGATOR
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