Dr. Kopetz on the Rationale for the BREAKWATER Trial in BRAF V600E-Mutant mCRC

Edmund Scott Kopetz, MD, PhD, FACP, professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the rationale for the ongoing phase 3 BREAKWATER trial (NCT04607421) in BRAF V600E-mutant metastatic colorectal cancer (mCRC).

During the 2022 Gastrointestinal Cancers Symposium, the study schema of the BREAKWATER trial will be presented as a trial in progress, Kopetz says. The study is building off the efficacy observed with the combination of encorafenib (Braftovi) and cetuximab (Erbitux) in the phase 3 BEACON CRC trial (NCT02928224) in patients with BRAF V600E-mutated mCRC who have progressed on 1 or 2 prior regimens in the metastatic setting.

BREAKWATER is currently enrolling patients with treatment-naïve, BRAF V600E-mutated mCRC to evaluate the efficacy and safety of encorafenib plus cetuximab with or without chemotherapy.

The study is seeking to answer remaining questions in this paradigm, such as whether a higher response rate will be observed when the combination is given in the frontline setting. Additionally, the trial will explore whether there is similar synergy between cytotoxic and targeted therapies in this patient population as has been observed in other settings in CRC, Kopetz concludes.