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


Phase 2
21 Years
75 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Change in Serum VEGF in Breast Cancer

Outcome Description:

Change in serum VEGF from baseline to post treatment with polyphenon E.

Outcome Time Frame:

Baseline and 4 to 6 weeks

Safety Issue:

No

Principal Investigator

Gary Burton, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

LSU Health Sciences Center Shreveport

Authority:

United States: Food and Drug Administration

Study ID:

H04-179

NCT ID:

NCT00676793

Start Date:

May 2004

Completion Date:

July 2013

Related Keywords:

  • Breast Cancer
  • breast cancer
  • EGCG
  • Polyphenon E
  • c-Met
  • VEGF
  • HGF
  • Breast Neoplasms
  • Neoplastic Processes

Name

Location
Columbia Presbyterian Hospital New York, New York  10032
LSU Health Sciences Center Shreveport, Louisiana  71130-3932