Breast Cancer Clinical Trial
A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression
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.
Full 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 Criteria
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 2 Locations for this study
Shreveport Louisiana, 71103, United States
New York New York, 10032, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.