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Trial Summary

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

Acronym:

BREAKWATER

ACTRN/NCT /ethics:

NCT04607421

Scientific 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

Sponsor / Cooperative group:

Pfizer

Trial & Patient Characteristics

Cancer TypeBowel and colon
Trial TypeTreatment
PhasePhase III
Age Range16 years and older
SexBoth
Tumour Stream -
Cancer StageMetastatic or Widespread
Anticipated Start Date2020-12-21
Anticipated End Date2026-11-15

Participating Hospitals

HospitalThe Queen Elizabeth Hospital
Clinical Trial CoordinatorPamela Cooper
Emailpamela.cooper@sa.gov.au
Phone08 8222 6410
Principal InvestigatorDr Amanda Townsend
Recruitment StatusRecruiting