Trial details
"AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF FIRST-LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND CETUXIMAB PLUS CHEMOTHERAPY IN PARTICIPANTS WITH METASTATIC BRAF V600E-MUTANT COLORECTAL CANCER"
To find out more about this trial and your cancer treatment options, please speak with your doctor.
Trial short name: BREAKWATER
Official title: "AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF FIRST-LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND CETUXIMAB PLUS CHEMOTHERAPY IN PARTICIPANTS WITH METASTATIC BRAF V600E-MUTANT COLORECTAL CANCER"
Principal Investigator: Dr. Michael Raphael
Cancer type: Gastrointestinal
Cancer location: Gastrointestinal
Disease stage: Early Cancer
Trial phase: Phase 3
Intervention: Encorafenib
Registration #:
NCT04607421 
Trial description:
"The purpose of the study is to evaluate whether encorafenib plus cetuximab (EC), alone or in
combination with chemotherapy, can improve clinical outcomes relative to current standard
of care chemotherapy in participants with previously untreated BRAF V600E-mutant mCRC.
Since encorafenib has not previously been combined with chemotherapy, the tolerability and
PK of EC in combination with mFOLFOX6 and in combination with FOLFIRI will be
evaluated in separate cohorts in the SLI portion of the trial in order to identify which
chemotherapy combination is to be used in the Phase 3 portion of the study."
Inclusion Criteria • Male or female participants age ≥18 years at the time of informed consent • Participants with histologically or cytologically confirmed colorectal adenocarcinoma • Participants with evidence of Stage IV metastatic disease. • ECOG performance status of 0 or 1. •Presence of a BRAF V600E mutation in tumor tissue or blood • Participants who have received ≤1 (SLI) or no (Phase 3) prior systemic regimens for metastatic disease Exclusion Criteria • Presence of acute or chronic pancreatitis • Known DPD deficiency • Leptomeningeal disease • Active hepatitis B or hepatitis C infection • Participants positive for HIV • Previous treatment with any selective BRAF inhibitor (eg, encorafenib, dabrafenib, vemurafenib, XL281/BMS-908662) or any EGFR inhibitor (eg, cetuximab, panitumumab) prior to screening.
