A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression
NCT ID: NCT00676793
Last Updated: 2017-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2004-05-31
2013-07-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
Polyphenon E
Four 200mg capsules daily taken with a meal, for the duration of the study.
Interventions
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Polyphenon E
Four 200mg capsules daily taken with a meal, for the duration of the study.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
75 Years
FEMALE
No
Sponsors
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Columbia University
OTHER
Louisiana State University Health Sciences Center Shreveport
OTHER
Responsible Party
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Jerry McLarty
Professor
Principal Investigators
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Gary Burton, M.D.
Role: PRINCIPAL_INVESTIGATOR
LSU Health Sciences Center Shreveport
Locations
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LSU Health Sciences Center
Shreveport, Louisiana, United States
Columbia Presbyterian Hospital
New York, New York, United States
Countries
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References
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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
Other Identifiers
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H04-179
Identifier Type: -
Identifier Source: org_study_id