Groupe d'Etude en Oncologie du Quebec

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
Protocole ID	BREAKWATER (C4221015)
ClinicalTrials.gov ID	NCT04607421
Cancer Type(s)	Colon and Rectum
Phase	Phase III
Stage	Metastatic
Study Type	Clinical
Drug	Encorafenib + cétuximab avec ou sans chimiothérapie versus traitement standard avec encorafenib + cétuximab et chimiothérapie
Institution	CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS 3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
City
Principal Investigator	Dr. Petr Kavan
Coordinator	Rhythm Sharma 514-340-8222 poste 28248
Status	Recruiting
Activation Date
Eligibility Criteria	Safety Lead-In = Male/female ≥ 18 years old Phase 3: Male/female ≥ 16 years old (where permitted locally) Histologically or cytologically confirmed Stage IV CRC that contains BRAF V600E mutation Prior systemic treatment in metastatic setting SLI: 0-1 regimens Phase 3: None Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis < 6 month from end of adj/neoadjuvant treatment Measurable disease (Phase 3)/ Measurable or evaluable disease (Safety Lead-in) ECOG PS 0-1 Adequate organ function
Exclusion Criteria	Tumors that are locally confirmed or unknown MSI-H or dMMR unless participant is ineligible to receive immune checkpoint inhibitors due to a pre-existing medical condition Active bacterial or viral infections in 2 weeks prior to starting dosing Symptomatic brain metastases

Groupe d'étude en oncologie du Québec