Clinical Trial Results:
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
Summary
|
|
EudraCT number |
2008-002819-40 |
Trial protocol |
DE ES AT BE HU GB IT |
Global completion date |
24 May 2012
|
Paediatric regulatory details
|
|
Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
08 Jul 2016
|
First version publication date |
22 May 2015
|
Other versions |
|
Summary report(s) |
BO21976 (CTg receipt) |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.