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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Louisiana State University Health Sciences Center Shreveport.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Jerry McLarty, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier:
NCT00676793
First received: May 9, 2008
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Polyphenon E
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Louisiana State University Health Sciences Center Shreveport:

Primary Outcome Measures:
  • Change in Serum VEGF in Breast Cancer [ Time Frame: Baseline and 4 to 6 weeks ] [ Designated as safety issue: No ]
    Change in serum VEGF from baseline to post treatment with polyphenon E.

  • Change in Serum HGF and Breast Cancer [ Time Frame: Baseline and 4 to 6 weeks ] [ Designated as safety issue: No ]
    Change in serum HGF from baseline to post Polyphenol E treatment.


Enrollment: 32
Study Start Date: May 2004
Estimated Study Completion Date: July 2013
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676793

Locations
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
Principal Investigator: Gary Burton, M.D. LSU Health Sciences Center Shreveport
  More Information

No publications provided

Responsible Party: Jerry McLarty, Professor, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier: NCT00676793     History of Changes
Other Study ID Numbers: H04-179
Study First Received: May 9, 2008
Results First Received: September 2, 2011
Last Updated: September 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Louisiana State University Health Sciences Center Shreveport:
breast cancer
EGCG
Polyphenon E
c-Met
VEGF
HGF

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 24, 2014