Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284180
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2006-01-27
Brief Title:
Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 HER2neu Over-Expressing Metastatic Breast Cancer
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
Phase II Trial of Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 HER2neu Over-Expressing Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-07
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 research study involves the anti-cancer medication trastuzumab and the investigational drug vinflunine The purpose of this trials is to see if trastuzumab and vinflunine used in combination or vinflunine alone is effective in the treatment of metastatic breast cancer
Detailed Description:
If the tumor is HER2neu positive eligible patients will receive trastuzumab and vinflunine intravenously IV every 3 weeks
If the tumor is HER2neu negative eligible patients will receive vinflunine intravenously IV every 3 weeks
Patients whose cancer does not grow or decreases in size may continue to receive treatment until cancer progression Evaluation of cancer will be every 9 weeks
If the tumor is HER2neu negative eligible patients will receive vinflunine intravenously IV every 3 weeks
Patients whose cancer does not grow or decreases in size may continue to receive treatment until cancer progression Evaluation of cancer will be every 9 weeks
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