Published research · NCT04607421
BREAKWATER
Who was studied? People with bowel (colorectal) cancer that had spread and had a confirmed BRAF V600E mutation. The main phase 3 study and its FOLFIRI cohort studied first-line treatment: participants had not previously received drug treatment for their metastatic cancer.
What treatment did the study investigate?
The main comparison combined encorafenib (Braftovi), cetuximab and mFOLFOX6 chemotherapy. The two targeted medicines block cancer growth signals; mFOLFOX6 contains oxaliplatin, folinic acid and fluorouracil. A separate cohort investigated encorafenib and cetuximab with FOLFIRI, which uses irinotecan instead of oxaliplatin. These are different chemotherapy combinations.
Independent clinical review is pending. Our explanations are a reading aid. Check the original record and discuss anything unclear with your care team.
What did the published results show?
The main mFOLFOX6 comparison reported longer time before the cancer worsened or the patient died, and longer overall survival, than standard chemotherapy with or without bevacizumab. Serious adverse events were more frequent with the combination. These results describe study groups; they do not predict an individual person's outcome.
Previous treatment matters. Results from first-line treatment cannot be assumed to apply in the same way after other treatments, including previous encorafenib and cetuximab. An oncologist needs to assess the evidence for each person's situation.
Can someone join the study or receive the treatment?
Registry checked 8 October 2026: active, not recruiting. This is a dated status check, not a live promise of availability. Check the current BREAKWATER registry record.
Receiving a treatment outside a trial is a separate question from joining the study. The UK prescribing information includes encorafenib with cetuximab and FOLFOX for first-line BRAF V600E metastatic colorectal cancer. A licence does not establish NHS funding, insurance cover or suitability for an individual. Ask the oncology team about the exact combination and access.
Read the evidence
- Main BREAKWATER results — New England Journal of Medicine, May 2025
- Separate FOLFIRI cohort — published results, 2026
- UK Braftovi prescribing information
A question for the care team: “Does the BREAKWATER evidence apply given my previous treatment, and which chemotherapy combination would you consider?”
Summary sources checked 8 October 2026. Independent clinical review is pending. This is research information to discuss with the care team, not a personal treatment plan.