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RecruitingLast updated: 7 February 2024

BREAKWATER: This phase III trial is evaluating whether targeted therapy, alone or in combination with chemotherapy, is more effective than standard care in patients with metastatic colorectal (bowel) cancerAN 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

Clinical summary

Summary

Since Encorafenib (EC) has not previously been combined with chemotherapy, the tolerability and pharmacokinetics of EC in combination with mFOLFOX6 and FOLFIRI will be evaluated in a separate safety lead-in portion of the trial. This portion of the trial will be undertaken in order to identify which chemotherapy combination should be used in the second phase of the trial. Patients enrolled in the second phase of the trial will be randomised to receive Encorafenib plus Cetuximab alone or in combination with the chemotherapy selected in the first phase.

Conditions

This trial is treating patients with colorectal (bowel) cancer.

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People16+

Phase

III

Trial Acronym

BREAKWATER

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Pfizer

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

Eligibility

Inclusion

  • Safety Lead-In = Male/female ≥ 18 years old
  • Phase 3 and Cohort 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: 0-1 regimens for Safety Lead In; none for Phase 3 and Cohort 3. (Note: Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis < 6 month from end of adj/neoadjuvant treatment )
  • Measurable disease (Phase 3 and Cohort 3)/ Measurable or evaluable disease (Safety Lead-in)
  • ECOG PS 0-1
  • Adequate organ function

Exclusion

  • 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

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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