BIBW 2992 (Afatinib) and Vinorelbine
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.
Carcinoma Breast Stage IV
Drug: BIBW 2992 in combination with vinorelbine
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Progression-free survival based on tumor imaging according to RECIST 1.1 criteria. [ Time Frame: 6 months defined as the time from the date of treatment start ] [ Designated as safety issue: No ]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. The analysis will be based upon the evaluation of tumour imaging. Disease progression will be evaluated according to the RECIST 1.1 criteria.
- Overall survival including assessment of objective response rate and time to progression. [ Time Frame: From start of treatment until the date of first documented progression or death from any cause, whichever came first, assessed approximately up to 24 months. ] [ Designated as safety issue: No ]Objective Response Rate based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1), Time-to-Progression and Overall Survival.
- Number, intensity and incidence of adverse events [ Time Frame: Start of treatment up to 28 days after the last administration trial medication. ] [ Designated as safety issue: Yes ]Safety will be evaluated as indicated by number, intensity and incidence of adverse events, graded according to US NCI CTCAE Version 4.0.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Drug: BIBW 2992 in combination with vinorelbine
|Contact: Joachim Bischoff, MD||0049 391 67 17301||Joachim.Bischoff@med.ovgu.de|
|Klinikum St. Marien Amberg||Not yet recruiting|
|Amberg, Bayern, Germany, 92224|
|München, Bayern, Germany, 80638|
|Caritas-Krankenhaus, Onkologisches Zentrum Regensburg||Recruiting|
|Regenburg, Bayern, Germany, 93053|
|Hildesheim, Niedersachsen, Germany, 31134|
|Schwerpunktpraxis für Hämatologie und Onkologie||Recruiting|
|Bottrop, Nordrhein-Westfalen, Germany, 46236|
|Universitätsklinikum Frauenklinik Düsseldorf||Recruiting|
|Düsseldorf, Nordrhein-Westfalen, Germany, 40225|
|Otto-von-Guericke-Universität Frauenklinik Magdeburg||Recruiting|
|Magdeburg, Sachsen-Anhalt, Germany, 39108|
|Klinikum Chemnitz gGmbH||Recruiting|
|Chemnitz, Sachsen, Germany, 09116|
|Onkologisches Zentrum Süd, Vivantes Tumorzentrum||Recruiting|
|Berlin, Germany, 12351|
|Praxisklinik Krebsheilkunde für Frauen / Brustzentrum||Recruiting|
|Berlin, Germany, 10367|
|Internistische Praxisgemeinschaft Eppendorf||Recruiting|
|Hamburg, Germany, 20249|
|OncoResearch Lerchenfled UG||Recruiting|
|Hamburg, Germany, 22081|
|Principal Investigator:||Joachim Bischoff, MD||Otto-von-Guericke-Universität Magdeburg, Germany|