Clinical trial NCT00676793: A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
EGCG
Polyphenon E
c-Met
VEGF
HGF
Lead sponsor: Louisiana State University Health Sciences Center Shreveport
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2008-05-13
Enrollment: 32
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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 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

Primary outcomes:
measure: Change in Serum VEGF in Breast Cancer
timeFrame: Baseline and 4 to 6 weeks
measure: Change in Serum HGF and Breast Cancer
timeFrame: Baseline and 4 to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: New York
country: United States
facility: Columbia Presbyterian Hospital
state: New York
Study officials:
affiliation: LSU Health Sciences Center Shreveport
name: Gary Burton, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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