A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression
Phase II Clinical Trial to Determine if Polyphenon E Inhibits c-Met Signaling and Activation of Pathways Contributing to Breast Cancer Progression
Study Overview
Detailed 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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Louisiana
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Shreveport, Louisiana, United States, 71103
- LSU Health Sciences Center
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New York
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New York, New York, United States, 10032
- Columbia Presbyterian Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Polyphenon E
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.
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Four 200mg capsules daily taken with a meal, for the duration of the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Serum VEGF in Breast Cancer
Time Frame: Baseline and 4 to 6 weeks
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Change in serum VEGF from baseline to post treatment with polyphenon E.
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Baseline and 4 to 6 weeks
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Change in Serum HGF and Breast Cancer
Time Frame: Baseline and 4 to 6 weeks
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Change in serum HGF from baseline to post Polyphenol E treatment.
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Baseline and 4 to 6 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Gary Burton, M.D., LSU Health Sciences Center Shreveport
Publications and helpful links
General Publications
- Proffered Oral Presentations - Intervention Studies Abstract PR-05: Effects of presurgical administration of tea polyphenols in women with operable breast cancer Julie L. Campbell1, James Cardelli2, Jerry McLarty2, Dawn Hershman1, Bret Taback1, Susan Refice1, Stephanie Wang2, Rebecca Bigelow2 and Katherine Crew1 1Columbia University Medical Center, New York, NY 2Louisiana State University Health Sciences Center, Shreveport, LA Cancer Prevention Research: December 2010; Volume 3, Issue 12, Supplement 2. doi: 10.1158/1940-6207.PREV-10-PR-05
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H04-179
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