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RecruitingLast updated:15 August 2023

BREAKWATER: This phase III trial is evaluating whether targeted therapy, alone or in combination with chemotherapy, is more effective than standard care in patients with metastatic colorectal (bowel) cancerAN 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

Clinical summary Eligibilty Participating hospital Support

Clinical summary

Summary

Since Encorafenib (EC) has not previously been combined with chemotherapy, the tolerability and pharmacokinetics of EC in combination with mFOLFOX6 and FOLFIRI will be evaluated in a separate safety lead-in portion of the trial. This portion of the trial will be undertaken in order to identify which chemotherapy combination should be used in the second phase of the trial. Patients enrolled in the second phase of the trial will be randomised to receive Encorafenib plus Cetuximab alone or in combination with the chemotherapy selected in the first phase.

Age

People 16+

Phase

III

Trial Acronym

BREAKWATER

More information

Trial Identifiers

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NCT04607421
C4221015- CT1291

Commercial Sponsor

Pfizer

Scientific 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

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