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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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 22 May 2024

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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; The BREAKWATER Study
  • Sponsors Pfizer
  • Most Recent Events

    • 29 Apr 2024 Planned primary completion date changed from 16 Nov 2024 to 6 Jan 2025.
    • 29 Feb 2024 According to Pfizer media release, the company anticipates the readouts from this study in the first half of 2025.
    • 06 Jun 2023 Randomization to Arm A ceased upon site institutional review board/ethics committee and competent authority approval of protocol amendment 5 and Cohort 3 to begin after phase 3 enrollment is complete which began in Nov 2021, according to trial design presented at the 59th Annual Meeting of the American Society of Clinical Oncology.
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