Ignite Creation Date:
2024-05-05 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 9:49 AM
Study NCT ID:
NCT00679341
Status:
COMPLETED
Last Update Posted:
2014-01-09
First Post:
2008-05-14
Brief Title:
A Study of the Efficacy and Safety of Trastuzumab Emtansine Trastuzumab-MCC-DM1 vs Trastuzumab Herceptin and Docetaxel Taxotere in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Multicenter Phase ii Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 vs Trastuzumab Herceptin and Docetaxel Taxotere in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease
Status:
COMPLETED
Status Verified Date:
2013-12
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 was a Phase II randomized multicenter international 2-arm open-label clinical trial designed to explore the efficacy and safety of trastuzumab emtansine T-DM1 relative to the combination of trastuzumab and docetaxel in patients with human epidermal growth factor receptor 2 HER2-positive unresectable locally advanced breast cancer andor metastatic breast cancer who have not received prior chemotherapy for metastatic disease
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TDM4450g | OTHER | Genentech | None |