A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression

August 23, 2017 updated by: Jerry McLarty, Louisiana State University Health Sciences Center Shreveport

Phase II Clinical Trial to Determine if Polyphenon E Inhibits c-Met Signaling and Activation of Pathways Contributing to Breast Cancer Progression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Sciences Center
    • New York
      • New York, New York, United States, 10032
        • Columbia Presbyterian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
Drug: Polyphenon E
Four 200mg capsules daily taken with a meal, for the duration of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum VEGF in Breast Cancer
Time Frame: Baseline and 4 to 6 weeks
Change in serum VEGF from baseline to post treatment with polyphenon E.
Baseline and 4 to 6 weeks
Change in Serum HGF and Breast Cancer
Time Frame: Baseline and 4 to 6 weeks
Change in serum HGF from baseline to post Polyphenol E treatment.
Baseline and 4 to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louisiana State University Health Sciences Center Shreveport

Collaborators

Columbia University

Investigators

  • Principal Investigator: Gary Burton, M.D., LSU Health Sciences Center Shreveport

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

May 9, 2008

First Submitted That Met QC Criteria

May 12, 2008

First Posted (Estimate)

May 13, 2008

Study Record Updates

Last Update Posted (Actual)

September 21, 2017

Last Update Submitted That Met QC Criteria

August 23, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H04-179

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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