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