Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095706
Status:
COMPLETED
Last Update Posted:
2015-09-25
First Post:
2004-11-05
Brief Title:
Treatment of HER2-Positive Metastatic Breast Cancer With Herceptin and Bevacizumab Antibodies Against HER2 and VEGF
Sponsor:
Translational Oncology Research International
Organization:
Translational Oncology Research International
Study Overview
Official Title:
Phase III Combined Biological Therapy of Breast Cancer Using Monoclonal Antibodies Directed Against HER2Neu Proto-Oncogene and Vascular Endothelial Growth Factor
Status:
COMPLETED
Status Verified Date:
2015-09
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:
The purpose of this study is to evaluate the safety and effectiveness of combined treatment with trastuzumab Herceptin and bevacizumab anti-VEGF antibody in patients with HER2-positive metastatic breast cancer
Detailed Description:
Based on preclinical experiments conducted in our laboratories we hypothesize that the aggressive behavior of HER2-overexpressing breast cancers is due in part to increased angiogenesis resulting from HER2-induced increases in vascular endothelial growth factor VEGF expression In vivo experiments suggest that combined blockade of the HER2 receptor and VEGF results in superior anti-tumor efficacy compared with either treatment alone
The current clinical trial for which the phase I portion has been completed will examine the efficacy and safety of trastuzumab Herceptin and bevacizumab anti-VEGF antibody in the treatment of HER2-overexpressing metastatic breast cancer
The current clinical trial for which the phase I portion has been completed will examine the efficacy and safety of trastuzumab Herceptin and bevacizumab anti-VEGF antibody in the treatment of HER2-overexpressing metastatic breast cancer
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA IRB 01-09-030 | None | None | None |
| Western IRB 20041069 | None | None | None |