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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. [Eine einarmige, offene, multizentrische Phase-II-Studie zum Nachweis der Wirksamkeit und Sicherheit von BIBW 2992 (Afatinib) in Kombination mit Vinorelbin zur Behandlung von Patientinnen mit metastasierendem Brustkrebs mit intermediärer HER2-Expression (HER2 2+ in der Immunhistochemie, Fluoreszenz in situ Hybridisierung (FISH) negativ) nach Versagen der Erstbehandlung der metastasierenden Erkrankung und Vorbehandlung mit Anthrazyklinen].

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Trial Profile

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. [Eine einarmige, offene, multizentrische Phase-II-Studie zum Nachweis der Wirksamkeit und Sicherheit von BIBW 2992 (Afatinib) in Kombination mit Vinorelbin zur Behandlung von Patientinnen mit metastasierendem Brustkrebs mit intermediärer HER2-Expression (HER2 2+ in der Immunhistochemie, Fluoreszenz in situ Hybridisierung (FISH) negativ) nach Versagen der Erstbehandlung der metastasierenden Erkrankung und Vorbehandlung mit Anthrazyklinen].

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 01 Aug 2022

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At a glance

  • Drugs Afatinib (Primary) ; Vinorelbine
  • Indications Advanced breast cancer
  • Focus Adverse reactions; Therapeutic Use

    • Most Recent Events

    • 17 Oct 2013 Status changed from recruiting to discontinued as reported by ClinicalTrials.gov.
    • 06 May 2012 New source identified and integrated (EudraCT2011-001765-41; European Clinical Trials Database).
    • 27 Apr 2012 Actual initiation date (Apr 2012) added as reported by ClinicalTrials.gov.
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