Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392392
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
2006-10-25
Brief Title:
Preoperative Bevacizumab and Trastuzumab With ABI-007 and Carboplatin in HER2 Breast Cancer
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
Phase II Study of Preoperative Bevacizumab and Trastuzumab Administered With ABI-007 and Carboplatin in HER2 Overexpressing Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-09
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:
This trial combines trastuzumab and bevacizumab monoclonal antibodies with ABI-007 and carboplatin as neoadjuvant therapy in previously untreated locally advanced breast cancers demonstrating HER2 gene amplification It is hoped that this novel combination will result in increased pathologic response rates that will translate into long term outcome improvements in HER2 positive patients with locally advanced breast cancer
Detailed Description:
All eligible patients will receive induction chemotherapy prior to consideration of primary surgical intervention If surgical intervention is deemed not to be in the best interest of the patient patient will go off study at the time of evaluation for surgery Upon completion of chemotherapy and surgery all ER andor PR patients will be placed on Tamoxifen 20 mgqd or an aromatase inhibitor
Induction preoperative therapy
Bevacizumab
Trastuzumab
ABI-007
Carboplatin
Postoperative Adjuvant Therapy
Bevacizumab
Trastuzumab
Induction preoperative therapy
Bevacizumab
Trastuzumab
ABI-007
Carboplatin
Postoperative Adjuvant Therapy
Bevacizumab
Trastuzumab
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