Ignite Creation Date:
2024-05-05 @ 9:40 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00934856
Status:
COMPLETED
Last Update Posted:
2017-04-06
First Post:
2009-07-06
Brief Title:
A Study of Trastuzumab Emtansine T-DM1 in Combination With Docetaxel and Potentially Pertuzumab in Participants With Advanced Breast Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-Label Multi-Center Phase III Study of the Safety and Tolerability of the Combination of Trastuzumab-MCC-DM1 T-DM1 With Docetaxel and Potentially Pertuzumab for Treatment for Patients With Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-02
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 an open-label multi-center non-randomized study of the safety and tolerability of the combination of T-DM1 plus docetaxel for the treatment of participants with metastatic breast cancer MBC and of T-DM1 plus docetaxel with or without pertuzumab for the treatment of participants with locally advanced breast cancer LABC The study comprises an initial dose finding feasibility part to determine the maximum tolerated dose MTD of T-DM1 and docetaxel followed by an extension part aiming to consolidate the safety and efficacy of the recommended docetaxelT-DM1 combination regimen
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 |
|---|---|---|---|
| 2009-010000-28 | EUDRACT_NUMBER | None | None |