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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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Sep 2026

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At a glance

  • Drugs Cetuximab (Primary) ; Encorafenib (Primary) ; Bevacizumab; Capecitabine; Fluorouracil; Folinic acid; Irinotecan; Oxaliplatin
  • Indications Adenocarcinoma; Colorectal cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms BREAKWATER
  • Sponsors Pfizer

Most Recent Events

  • 04 Aug 2026 Results presented in the Pfizer media release.
  • 14 Jul 2026 According to a Merck KGaA media release, based on results of pivotal phase 3 BREAKWATER trial, European Commission (EC) approved an update to the Erbitux (cetuximab) EU label on June 26, 2026, in first-line treatment in combination with FOLFOX (BREAKWATER regimen).
  • 05 Jun 2026 According to Clinical Trials Information System this study is completed in Slovakia.

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