BRAF V600E-mutant Colorectal Cancer Study of Encorafenib Taken With Cetuximab Plus or Minus Chemotherapy (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
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Clinical Trial Information
Trial Contact: Djuro, Victor; Donaldson, Karin M
Trial Phone: 321.841.7477 ; 321.841.9821
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IRB No: 20202585
Protocol Abbrev: C4221015
Principal Investigator: Omar R. Kayaleh, MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: BreakWater
Treatment: Drug: Encorafenib Drug: Cetuximab Drug: Oxaliplatin Drug: Irinotecan Drug: Leucovorin Drug: 5-FU Drug: Capecitabine Drug: Bevacizumab
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT04607421
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Objective
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
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Key Eligibility
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
