Clinical trial · no report yet · Phase 3
NCT04607421
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
- NCT04607421 ↗
- Active, not recruiting
- Pfizer
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| Bluesky threads | 2 | |
| X threads | 1 |
The trial
ClinicalTrials.gov- Official 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
- Phase
- Phase 3
- Status
- Active, not recruiting
- Conditions
- Neoplasms
- Interventions
- Encorafenib; Cetuximab; Oxaliplatin; Irinotecan; Leucovorin; 5-FU; Capecitabine; Bevacizumab
- Arms
- Safety Lead-in Cohort 1 · Experimental
- Safety Lead-in Cohort 2 · Experimental
- Phase 3 Arm A · Experimental
- Phase 3 Arm B · Experimental
- Phase 3 Arm C · Active comparator
- Cohort 3 Arm D · Experimental
- Cohort 3 Arm E · Active comparator
- Enrollment
- 841
- Primary outcomes
- SLI: Number of Participants With Dose Limiting Toxicity (DLTs)
- Phase 3: Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) for Arm B vs Arm C - FAS
- Phase 3: Objective Response Rate (ORR) as Assessed by BICR for Arm B vs Arm C - FAS ORR Subset
- Cohort 3: ORR as Assessed by BICR for Arm D vs Arm E - FAS
- Sponsor
- Pfizer with Ono Pharmaceutical Co., Ltd., Merck KGaA, Darmstadt, Germany, Eli Lilly and Company
- Start
- Dec 21, 2020
- Primary completion
- Mar 1, 2025
- Results posted
- Yes
- Registry record
- NCT04607421 · updated Jun 11, 2026
Publications
linked from the registry- Kopetz S, Tabernero J, Elez E. BREAKWATER Phase III: results for encorafenib and cetuximab plus mFOLFOX6 in first-line BRAF V600E-mutant metastatic colorectal cancer. Future Oncol. 2025 Dec;21(28):3585-3588. doi: 10.1080/14796694.2025.2579882. Epub 2025 Nov 13. PubMed 41230651
- Elez E, Yoshino T, Shen L, Lonardi S, Van Cutsem E, Eng C, Kim TW, Wasan HS, Desai J, Ciardiello F, Yaeger R, Maughan TS, Morris VK, Wu C, Usari T, Laliberte R, Dychter SS, Zhang X, Tabernero J, Kopetz S; BREAKWATER Trial Investigators. Encorafenib, Cetuximab, and mFOLFOX6 in BRAF-Mutated Colorectal Cancer. N Engl J Med. 2025 Jun 26;392(24):2425-2437. doi: 10.1056/NEJMoa2501912. Epub 2025 May 30. PubMed 40444708
- Kopetz S, Yoshino T, Van Cutsem E, Eng C, Kim TW, Wasan HS, Desai J, Ciardiello F, Yaeger R, Maughan TS, Beyzarov E, Zhang X, Ferrier G, Zhang X, Tabernero J. Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: a randomized phase 3 trial. Nat Med. 2025 Mar;31(3):901-908. doi: 10.1038/s41591-024-03443-3. Epub 2025 Jan 25. PubMed 39863775
- Van Cutsem E, Taieb J, Yaeger R, Yoshino T, Grothey A, Maiello E, Elez E, Dekervel J, Ross P, Ruiz-Casado A, Graham J, Kato T, Ruffinelli JC, Andre T, Carriere Roussel E, Klauck I, Groc M, Vedovato JC, Tabernero J. ANCHOR CRC: Results From a Single-Arm, Phase II Study of Encorafenib Plus Binimetinib and Cetuximab in Previously Untreated BRAFV600E-Mutant Metastatic Colorectal Cancer. J Clin Oncol. 2023 May 10;41(14):2628-2637. doi: 10.1200/JCO.22.01693. Epub 2023 Feb 10. PubMed 36763936