Ignite Creation Date:
2024-05-06 @ 3:58 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02419742
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2015-03-23
Brief Title:
Safety and Efficacy of Trastuzumab as Part of Breast Cancer Treatment Regimen
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Indian Multicentric Open Label Prospective Phase IV Study to Evaluate Safety and Efficacy of Trastuzumab in Her2 Positive Node Positive or High Risk Node Negative Breast Cancer as Part of a Treatment Regimen Consisting of Doxorubicin Cyclophosphamide With Either Docetaxel or Paclitaxel AC-TH or Docetaxel and Carboplatin TCH
Status:
COMPLETED
Status Verified Date:
2022-09
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 is a prospective Phase IV multi-center single arm open-label interventional study to evaluate the safety of trastuzumab for the treatment of human epidermal growth factor receptor 2 protein HER2-positive node positive or high risk node negative breast cancer participants with regimen consisting of doxorubicin and cyclophosphamide followed by either paclitaxel or docetaxel AC-TH Regimen or a regimen consisting of docetaxel and carboplatin TCH Regimen in Indian population
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None