Clinical Trial Results:
Single-arm, open-label, multicentre phase II study evaluating the efficacy and safety of BIBW 2992 (Afatinib) in combination with vinorelbine for the treatment of patients with metastatic breast cancer with intermediate HER2 expression (HER2 2+ by immunohistochemistry, fluorescence in-situ hybridisation (FISH) negative) after failure of first-line therapy in the metastatic setting and having been pre-treated with anthracyclines
Summary
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EudraCT number |
2011-001765-41 |
Trial protocol |
DE |
Global completion date |
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
12 Mar 2021
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First version publication date |
12 Mar 2021
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Other versions |
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Summary report(s) |
Study report |
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.