West Cancer Center

COLORECTAL: METASTATIC: 1ST LINE: BRAF MT: BREAKWATER

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

Title

Pfizer C4221015 (BRAF mt CRC, BREAKWATER)

Study Title

Site Link

NCT04607421

Malignancy

Colon, Rectum, Colorectal

Stage

Stage 4

Disease Setting

Line Of Therapy

Investigational Agent

Encorafenib, cetuximab

Drug Class

BRAF inhibitor, EGFR antibody

Sponsor

Pfizer

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Age 16 or greater
Histologically or cytologically confirmed Stage IV CRC
Must contain a BRAF V600E mutation on local (FMI or Caris) or central testing
No prior systemic treatment in metastatic setting
Prior adjuvant or neoadjuvant therapy is OK only if relapse/metastasis is 6 months or greater from the end of the neo/adjuvant treatment
No history of acute or chronic pancreatitis
No symptomatic brain mets
Must have measurable disease

Objective

Primary
- OS
Secondary
- ORR
- DoR
- TTR
- PFS
- PFS2
- Safety
- QOL

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes