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BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment
Sponsor: Pierre Fabre Pharma GmbH
Summary
The presence of a BRAFV600E mutation is a marker of poor prognosis in patients with mCRC and associated with a median overall survival (mOS) of approximately 12 to 14 months compared to 20 to 25 months for patients with BRAF wild-type tumours. After 1st line therapy, treatment outcomes with standard therapy are poor in patients with BRAF-mutated mCRC, with response rates (ORR) of ≤ 11%, a median progression-free survival (mPFS) between 1.8 and 2.8 months, and a mOS between 4.1 and 6.2 months. Failure to achieve adequate survival outcomes with standard treatment regimens in patients with BRAF-mutated mCRC has encouraged efforts to combine multiple targeted therapies: With 665 randomized patients, the BEACON CRC trial represents the largest trial and is currently the only phase III study in patients with BRAFV600E-mutant mCRC. BERING CRC - designed as a prospective (allowing initial retrospective documentation), longitudinal, non-interventional study - will investigate the real-world effectiveness, quality of life, safety and tolerability of encorafenib and cetuximab in BRAFV600E-mutant mCRC patients, who have received prior systemic therapy. Data from this study will contribute to a deeper understanding and characterization to the everyday use of encorafenib and cetuximab in a broader patient population in the German, Austrian, and Swiss routine setting.
Official title: Encorafenib and Cetuximab in Patients With Metastatic, BRAFV600E-mutated, Colorectal Carcinoma: a Multi-centric, Multi-national, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2020-09-03
Completion Date
2027-01
Last Updated
2022-09-29
Healthy Volunteers
No
Conditions
Interventions
Encorafenib
Observation of real-life treatment with encorafenib and cetuximab
Cetuximab
Observation of real-life treatment with encorafenib and cetuximab
Locations (70)
Clinic
Braunau am Inn, Upper Austria, Austria
Clinic
Linz, Upper Austria, Austria
Clinic
Feldkirch, Voralberg, Austria
Clinic
Vienna, Austria
Practice
Offenburg, Baden-Wurttemberg, Germany
Medical Care Centre
Ulm, Baden-Wurttemberg, Germany
Clinic
Ulm, Baden-Wurttemberg, Germany
Practice
Augsburg, Bavaria, Germany
Practice
Donauwörth, Bavaria, Germany
Clinic
Erlangen, Bavaria, Germany
Practice
München, Bavaria, Germany
Practice
Würzburg, Bavaria, Germany
Medical Car Centre
Aschaffenburg, Bayer, Germany
Medical Care Centre
Potsdam, Brandenburg, Germany
Practice
Celle, Lower Saxony, Germany
Medical Care Centre
Goslar, Lower Saxony, Germany
Practice
Göttingen, Lower Saxony, Germany
Medical Practice
Hanover, Lower Saxony, Germany
Practice
Hanover, Lower Saxony, Germany
Practice
Leer, Lower Saxony, Germany
Clinic
Weißenfels, Lower Saxony, Germany
Medical Practice
Wilhelmshaven, Lower Saxony, Germany
Practice
Rostock, Mecklenburg-Vorpommern, Germany
Practice
Rostock, Mecklenburg-Vorpommern, Germany
Clinic
Rostock, Melcklenburg-Vorpommern, Germany
Clinic
Aachen, North Rhine-Westphalia, Germany
Clinic
Bochum, North Rhine-Westphalia, Germany
Practice
Bonn, North Rhine-Westphalia, Germany
Clinic
Bonn, North Rhine-Westphalia, Germany
Practice
Bottrop, North Rhine-Westphalia, Germany
Clinic
Essen, North Rhine-Westphalia, Germany
Practice
Moers, North Rhine-Westphalia, Germany
Medical Care Centre
Mönchengladbach, North Rhine-Westphalia, Germany
Medical Care Centre
Mülheim, North Rhine-Westphalia, Germany
Medical Care Centre
Neuss, North Rhine-Westphalia, Germany
Clinic
Paderborn, North Rhine-Westphalia, Germany
Medical Care Centre
Porta Westfalica, North Rhine-Westphalia, Germany
Practice
Stolberg, North Rhine-Westphalia, Germany
Practice
Troisdorf, North Rhine-Westphalia, Germany
Clinic
Wuppertal, North Rhine-Westphalia, Germany
Practice
Bad Kreuznach, Rhineland-Palatinate, Germany
Practice
Kaiserslautern, Rhineland-Palatinate, Germany
Practice
Worms, Rhineland-Palatinate, Germany
Clinic
Saarbrücken, Saarland, Germany
Practice
Dresden, Saxony, Germany
Prctice
Naunhof, Saxony, Germany
Clinic
Torgau, Saxony, Germany
Practice
Halle, Saxony-Anhalt, Germany
Clinic
Köthen, Saxony-Anhalt, Germany
Practice
Köthen, Saxony-Anhalt, Germany
Clinic
Flensburg, Schleswig-Holstein, Germany
Clinic
Eisenach, Thuringia, Germany
Hospital
Aschaffenburg, Germany
Medical Care Centre
Berlin, Germany
Practice
Berlin, Germany
Practice
Berlin, Germany
Clinic
Berlin, Germany
Private Practice
Berlin, Germany
Private Practice
Dresden, Germany
Hospital
Esslingen am Neckar, Germany
Practice
Hamburg, Germany
Practice
Hamburg, Germany
Private Practice
Heidelberg, Germany
Private Practice
Leer, Germany
Private Practice
Lübeck, Germany
Private Practice
Naunhof, Germany
Private Practice
Offenburg, Germany
Private Practice
Oldenburg in Holstein, Germany
Private Practice
Schorndorf, Germany
Private Practice
Würzburg, Germany