Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503750
Status:
COMPLETED
Last Update Posted:
2012-06-25
First Post:
2007-07-17
Brief Title:
Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 Abraxane
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 Abraxane Followed by Vinorelbine for HER2 Overexpressing Early Stage Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-06
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 is a phase II one arm study Patients with HER2 Human Epidermal Growth Factor Receptor 2positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with trastuzumab before having breast surgery
Detailed Description:
This is a phase II one arm study Patients with HER2Human Epidermal Growth Factor Receptor 2 positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with trastuzumab before having breast surgery
Approximately 50 patients will take part at multi-sites with potentially 20 patients participating at the Emory Winship Cancer Institute Grady Memorial Hospital and Emory Crawford Long Hospital in Atlanta Georgia
Approximately 50 patients will take part at multi-sites with potentially 20 patients participating at the Emory Winship Cancer Institute Grady Memorial Hospital and Emory Crawford Long Hospital in Atlanta Georgia
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