Finding studies
Finding studies
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Lead
Louisiana State University Health Sciences Center Shreveport
With
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
Age
21–75
Sex
FEMALE
Healthy volunteers
Not accepted