BREAKWATER — Encorafenib plus cetuximab, with or without chemotherapy, versus standard chemotherapy in previously untreated BRAF V600E-mutant metastatic colorectal cancer (BREAKWATER)

Phase 3 · Colorectal Cancer

Population

Previously untreated BRAF V600E-mutant metastatic colorectal cancer.

Primary Endpoint

Progression-free survival by blinded independent central review

Rationale

BRAF V600E-mutant colorectal cancer carries a poor prognosis, and the encorafenib-cetuximab doublet is established only after prior therapy. BREAKWATER tests whether moving BRAF-targeted therapy into the first line, alongside chemotherapy, improves outcomes over chemotherapy alone.

What It Could Change

Could make first-line encorafenib plus cetuximab and chemotherapy the new standard of care for BRAF V600E-mutant metastatic colorectal cancer.