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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00676793
Recruitment Status : Completed
First Posted : May 13, 2008
Results First Posted : October 26, 2012
Last Update Posted : September 21, 2017
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Jerry McLarty, Louisiana State University Health Sciences Center Shreveport

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Polyphenon E Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Phase II Clinical Trial to Determine if Polyphenon E Inhibits c-Met Signaling and Activation of Pathways Contributing to Breast Cancer Progression
Study Start Date : May 2004
Actual Primary Completion Date : December 2009
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676793


Locations
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United States, Louisiana
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71103
United States, New York
Columbia Presbyterian Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
Louisiana State University Health Sciences Center Shreveport
Columbia University
Investigators
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Principal Investigator: Gary Burton, M.D. LSU Health Sciences Center Shreveport
More Information
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Publications of Results:
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

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Responsible Party: Jerry McLarty, Professor, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier: NCT00676793    
Other Study ID Numbers: H04-179
First Posted: May 13, 2008    Key Record Dates
Results First Posted: October 26, 2012
Last Update Posted: September 21, 2017
Last Verified: August 2017
Keywords provided by Jerry McLarty, Louisiana State University Health Sciences Center Shreveport:
breast cancer
EGCG
Polyphenon E
 c-Met
VEGF
HGF
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases