Clinical Trial Results:
A phase III, randomized, open-label study to compare pharmacokinetics, efficacy and safety of subcutaneous (SC) trastuzumab with intravenous (IV) trastuzumab administered in women with HER2 positive early breast cancer (EBC).
Summary
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EudraCT number |
2008-007326-19 |
Trial protocol |
FR ES CZ EE DE GB SE IT SK HU |
Global completion date |
12 Jul 2011
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1 |
This version publication date |
08 Jul 2016
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First version publication date |
26 Jun 2015
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Other versions |
v2 |
Summary report(s) |
BO22227_Synopsis |
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.