BREAKWATER

NCT04607421 📎

Regimen

Experimental
Encorafenib + cetuximab + mFOLFOX6
Control
Investigator's choice chemotherapy (mFOLFOX6 + bevacizumab or cetuximab; or FOLFIRI + bevacizumab or cetuximab)

Population

BRAF V600E-mutant, RAS wild-type metastatic CRC, 1L, previously untreated.

Key finding

EC+mFOLFOX6 vs standard care (investigator choice): median PFS 12.8 vs 7.1 months (HR 0.53, 95% CI 0.41–0.68; P<0.001); interim OS 30.3 vs 15.1 months (HR 0.49, 95% CI 0.38–0.63; P<0.001); serious AEs during treatment: 46.1% vs 38.9%.

Source: PMID 40444708

Timeline

    Guideline citations

    • NCCN Colon (p.61)
    • NCCN Rectal (p.78)