Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT00392392
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
2006-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Preoperative Bevacizumab and Trastuzumab With ABI-007 and Carboplatin in HER2+ Breast Cancer
Sponsor:
SCRI Development Innovations, LLC
Organization:
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 + and/or PR + patients will be placed on Tamoxifen 20 mg/qd 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:
False
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?: