Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
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: 15 Mar 2026

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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

  • 24 Feb 2026 According to Pfizer media release, the U.S. Food and Drug Administration (FDA) has granted full approval to BRAFTOVI (encorafenib) in combination with cetuximab (marketed as ERBITUX) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation based on results from the global Phase 3 BREAKWATER trial (NCT04607421).
  • 17 Feb 2026 Primary endpoint has been met. (Cohort 3: Objective response rate by blinded independent review)
  • 17 Feb 2026 According to Pfizer media release, Positive ORR results were achieved and recently presented at the 2026 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top