A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression
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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 |
- 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 |
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| 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 | |
| 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 Neoplastic Processes Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013