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| Name | Class |
|---|---|
| Columbia University | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyphenon E | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyphenon E | Drug | Four 200mg capsules daily taken with a meal, for the duration of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum VEGF in Breast Cancer | Change in serum VEGF from baseline to post treatment with polyphenon E. | Baseline and 4 to 6 weeks |
| Change in Serum HGF and Breast Cancer | Change in serum HGF from baseline to post Polyphenol E treatment. | Baseline and 4 to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Burton, M.D. | LSU Health Sciences Center Shreveport | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LSU Health Sciences Center | Shreveport | Louisiana | 71103 | United States | ||
| Columbia Presbyterian Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | ECGC and Breast Cancer | Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ECGC and Breast Cancer | Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Serum VEGF in Breast Cancer | Change in serum VEGF from baseline to post treatment with polyphenon E. | Number of participants for analysis was determined per protocol. | Posted | Median | Inter-Quartile Range | pg/ml | Baseline and 4 to 6 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ECGC and Breast Cancer | Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach Cramps | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jerry w. McLarty, Ph.D. | LSU Health, Shreveport | (318)813-1446 | jmclar@lsuhsc.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C472086 | polyphenon E |
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| New York |
| New York |
| 10032 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Primary | Change in Serum HGF and Breast Cancer | Change in serum HGF from baseline to post Polyphenol E treatment. | Number of participants for analysis was determined per protocol. | Posted | Median | Inter-Quartile Range | pg/ml | Baseline and 4 to 6 weeks |
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|
|
|
| 0 |
| 32 |
| 3 |
| 32 |
| Increase in amylase and lypase | Renal and urinary disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |