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.
Written informed consent of the patient with regard to the pseudonymized documentation of his/her data in the frame of this non-interventional study
Legally capable patient ≥ 18 years of age (no upper limit)
Metastatic colorectal carcinoma with BRAFV600E-mutation, pretreated with systemic therapy
Decision was taken to treat the patient with the doublet therapy (encorafenib and cetuximab) in accordance with the current SmPC and by prescription; this decision was taken prior to and independent from the inclusion into the study;
More than 2 prior systemic regimens in the metastatic setting (adjuvant systemic therapy with relapse ≤ 6 months will be counted as metastatic treatment line; maintenance treatment will not be counted as separate metastatic treatment line)
Prior treatment with any RAF-inhibitor or MEK-inhibitor.
Presence of any contraindication with regard to the doublet therapy (encorafenib plus cetuximab) as specified in the corresponding SmPCs
Current or upcoming participation in an interventional clinical trial
Adult patients with metastatic, BRAFV600E-mutant, colorectal carcinoma, who have received prior systemic therapy, with the decision to receive the doublet therapy encorafenib plus cetuximab according to the current SmPC.
Cohort
Prospective
Encorafenib
DrugObservation of real-life treatment with encorafenib and cetuximab
Cetuximab
DrugObservation of real-life treatment with encorafenib and cetuximab
Overall Survival
Overall Survival rate
Patient and disease profiles at start of treatment with encorafenib plus cetuximab
Demographic and disease chracteristics
BRAF-mutation assessment
Date and type of BRAFV600E testing
Type and sequence of treatments before and after encorafenib plus cetuximab
Treatment sequence prior to and after encorafenib plus cetuximab
Characteristics of treatment with encorafenib plus cetuximab
Evaluation of reason for treatment selection (efficacy, safety profile, quality of life, patients preference, physician's preference, comorbidities, other)
Click on the lead sponsor to view all of their trials.
Pierre Fabre Pharma GmbH
Lead sponsor
iOMEDICO AG
Collaborator
Pierre Fabre Pharma AG
Collaborator
Pierre Fabre Pharma Austria
Collaborator
