Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment polyphenon e
Phase phase 2
Sponsor Louisiana State University Health Sciences Center Shreveport
Collaborator Columbia University
Start date May 2004
End date December 2009
Trial size 32 participants
Trial identifier NCT00676793, H04-179

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
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.
polyphenon e
Four 200mg capsules daily taken with a meal, for the duration of the study.

Primary Outcomes

Measure
Change in Serum VEGF in Breast Cancer
time frame: Baseline and 4 to 6 weeks
Change in Serum HGF and Breast Cancer
time frame: Baseline and 4 to 6 weeks

Eligibility Criteria

Female participants from 21 years up to 75 years old.

Inclusion Criteria: - Definitive biopsy demonstrating primary breast cancer - Residual breast cancer requiring additional surgical resection - Stage I, II or III disease - Patient has ability to give signed informed consent - Normal hepatic and renal function (creatinine<1.5, transaminases <1.5 times upper limit of normal). - ECOG Performance status of 0 or 1. - Age ≥ 21 years and less than 75 Exclusion Criteria: - Prior hormonal or surgical therapy for breast cancer - Abnormal liver function test - Liver or kidney problems that would interfere with metabolism of study drug - Any condition that would hamper informed consent or ability to comply with study protocol - Participation in another research study in the last three months - Known malignancy at any site other than breast - Recent consumption of green tea (5 or more cups per day, within one week prior to biopsy) - Allergy or intolerance to any component of green tea - Inability or refusal to comply with definitive surgical therapy

Additional Information

Official title Phase II Clinical Trial to Determine if Polyphenon E Inhibits c-Met Signaling and Activation of Pathways Contributing to Breast Cancer Progression
Principal investigator Gary Burton, M.D.
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by Louisiana State University Health Sciences Center Shreveport.