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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: 04 Jun 2025

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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

  • 30 May 2025 According to a Pfizer media release, company announced that data from this trial will be presented today in an oral presentation (Abstract LBA3500) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and have been simultaneously published in the New England Journal of Medicine.
  • 30 May 2025 Results presented in the Pfizer media release.
  • 22 May 2025 According to a Merck and Co media release, additional data from this study, evaluating the efficacy mFOLFOX6, encorafenib and ERBITUX combination in metastatic BRAF V600E-mutant CRC, will be featured in the Cancers of the Colon, Rectum, and Anus sessions at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, May 31 to June 4 in Chicago.

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