Ignite Creation Date:
2024-05-05 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 9:49 AM
Study NCT ID:
NCT00676793
Status:
COMPLETED
Last Update Posted:
2017-09-21
First Post:
2008-05-09
Brief Title:
A Study of the Effect of Polyphenon E Green Tea Extract on Breast Cancer Progression
Sponsor:
Louisiana State University Health Sciences Center Shreveport
Organization:
Louisiana State University Health Sciences Center Shreveport
Study Overview
Official Title:
Phase II Clinical Trial to Determine if Polyphenon E Inhibits c-Met Signaling and Activation of Pathways Contributing to Breast Cancer Progression
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
11 Determine the effects of Polyphenon E on tumor cell c-Met expression and phosphorylation levels in patients with breast cancer
12 Determine the effects of Polyphenon E on PI-3K activation in patients with breast cancer
13 Determine the effects of Polyphenon E on MAPK activation in patients with breast cancer
14 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
15 Determine the effects of Polyphenon E on markers of angiogenesis in patients with breast cancer
16 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
17 Evaluate the safety and tolerability of Polyphenon E in this subject population
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
11 Determine the effects of Polyphenon E on tumor cell c-Met expression and phosphorylation levels in patients with breast cancer
12 Determine the effects of Polyphenon E on PI-3K activation in patients with breast cancer
13 Determine the effects of Polyphenon E on MAPK activation in patients with breast cancer
14 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
15 Determine the effects of Polyphenon E on markers of angiogenesis in patients with breast cancer
16 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
17 Evaluate the safety and tolerability of Polyphenon E in this subject population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None