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Brief Title: BIBW 2992 (Afatinib) and Vinorelbine
Official Title: 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
Study ID: NCT01531764
Brief Summary: This open-label, single-arm, multicentre phase II trial will be performed in patients with intermediate HER2-positive, metastatic breast cancer (MBC)pretreated with anthracyclines and one first-line therapy in the metastatic setting. The main objective of the trial is to evaluate the efficacy and safety of BIBW 2992 in combination with vinorelbine in patients with intermediate HER2-positive MBC. If this trial shows promising results, further studies to evaluate the benefit of BIBW 2992 in combination with chemotherapy in this subgroup of intermediate HER2-positive patients with MBC are warranted. Patients will be followed until progression. After progression, for the purpose of analysing overall survival, information on vital status and subsequent treatment will be collected. The primary objective is to determine the 6-month progression free survival rate of BIBW 2992 and vinorelbine i.v. in patients with metastatic, HER2 IHC 2+, HER2 FISH-negative breast cancer. BIBW 2992 in combination with vinorelbine will provide a suitable combination to test the hypothesis that patients with metastatic breast cancer whose tumours are HER2 2+ by immunohistochemistry, but negative by fluorescence in-situ hybridisation (FISH) will benefit from a combination of a cytotoxic agent, i.e. vinorelbine, plus the dual irreversible EGFR/HER2-tyrosine kinase inhibitor BIBW 2992.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Klinikum St. Marien Amberg, Amberg, Bayern, Germany
Hämato-Onkologische Schwerpunktpraxis, München, Bayern, Germany
Caritas-Krankenhaus, Onkologisches Zentrum Regensburg, Regenburg, Bayern, Germany
Gynäkologische Praxis, Hildesheim, Niedersachsen, Germany
Schwerpunktpraxis für Hämatologie und Onkologie, Bottrop, Nordrhein-Westfalen, Germany
Universitätsklinikum Frauenklinik Düsseldorf, Düsseldorf, Nordrhein-Westfalen, Germany
Otto-von-Guericke-Universität Frauenklinik Magdeburg, Magdeburg, Sachsen-Anhalt, Germany
Klinikum Chemnitz gGmbH, Chemnitz, Sachsen, Germany
Praxisklinik Krebsheilkunde für Frauen / Brustzentrum, Berlin, , Germany
Onkologisches Zentrum Süd, Vivantes Tumorzentrum, Berlin, , Germany
Internistische Praxisgemeinschaft Eppendorf, Hamburg, , Germany
OncoResearch Lerchenfled UG, Hamburg, , Germany
Name: Joachim Bischoff, MD
Affiliation: Otto-von-Guericke-Universität Magdeburg, Germany
Role: PRINCIPAL_INVESTIGATOR