Effects of a green tea extract, Polyphenon E, on systemic biomarkers of growth factor signalling in women with hormone receptor-negative breast cancer.

Background Observational and experimental data support a potential breast cancer chemopreventive effect of green tea. Methods We conducted an ancillary study using archived blood/urine from a phase IB randomised, placebo-controlled dose escalation trial of an oral green tea extract, Polyphenon E (Poly E), in breast cancer patients. Using an adaptive trial design, women with stage I- III breast cancer who completed adjuvant treatment were randomised to Poly E 400 mg ( n = 16), 600 mg ( n = 11) and 800 mg ( n = 3) twice daily or matching placebo ( n = 10) for 6 months. Blood and urine collection occurred at baseline, and at 2, 4 and 6 months. Biological endpoints included growth factor [serum hepatocyte growth factor ( HGF), vascular endothelial growth factor ( VEGF)], lipid (serum cholesterol, triglycerides), oxidative damage and inflammatory biomarkers. Results From July 2007-August 2009, 40 women were enrolled and 34 (26 Poly E, eight placebo) were evaluable for biomarker endpoints. At 2 months, the Poly E group (all dose levels combined) compared to placebo had a significant decrease in mean serum HGF levels (−12.7% versus +6.3%, P = 0.04). This trend persisted at 4 and 6 months but was no longer statistically significant. For the Poly E group, serum VEGF decreased by 11.5% at 2 months ( P = 0.02) and 13.9% at 4 months ( P = 0.05) but did not differ compared to placebo. At 2 months, there was a trend toward a decrease in serum cholesterol with Poly E ( P = 0.08). No significant differences were observed for other biomarkers. Conclusions Our findings suggest potential mechanistic actions of tea polyphenols in growth factor signalling, angiogenesis and lipid metabolism.