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BRAF V600E-mutant Colorectal Cancer Study of Encorafenib Taken With Cetuximab Plus or Minus Chemotherapy (BREAKWATER)

Trial Status: Active

To evaluate whether encorafenib plus cetuximab (EC), alone or in combination with chemotherapy, can improve clinical outcomes relative to current standard of care chemotherapy in participants with previously untreated BRAF V600E-mutant mCRC

Inclusion 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

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Charlean Ketchens
Phone: 323-865-3035
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Charlean Ketchens
Phone: 323-865-3035

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Rona Denit Yaeger
Phone: 646-888-4179

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: IN_REVIEW

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: APPROVED

The purpose of the study is to evaluate whether encorafenib plus cetuximab (EC), alone or in

combination with chemotherapy, can improve clinical outcomes relative to current standard

of-care chemotherapy in participants with previously untreated BRAF V600E-mutant mCRC. Since

encorafenib has not previously been combined with chemotherapy, the tolerability and PK of EC

in combination with mFOLFOX6 and in combination with FOLFIRI will be evaluated in separate

cohorts in the safety lead-in portion of the trial in order to identify which chemotherapy

combination is to be used in the Phase 3 portion of the study.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Pfizer Inc

  • Primary ID C4221015
  • Secondary IDs NCI-2021-01687, 2020-001288-99
  • Clinicaltrials.gov ID NCT04607421