MOUNTAINEER-03 (Colorectal Cancer)

What is the Purpose of this Study?

We are doing this study to see how tucatinib, trastuzumab, and mFOLFOX6 work to treat cancer of your colon or rectum that is HER2-positive with mFOLFOX6 alone or combined with bevacizumab.

What is the Condition Being Studied?

Colorectal Cancer

Who Can Participate in the Study?

Adults with colorectal cancer who:

  • Have HER2+ mutation
  • Able to swallow oral medication
  • Have not had prior systemic anticancer therapy for colorectal cancer (CRC) in the metastatic setting

For more information about who can join this study, please contact the study team at sabina.wlazlo@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will get a random assignment (like the flip of a coin) to Group 1 or Group 2:

  • Group 1 will take tucatinib pills, mFOLFOX6 will be given into a vein (intravenous, "IV"), and trastuzumab will be given by IV.
  • Group 2 will get mFOLFOX6 by IV and bevacizumab by IV.

Participants in both groups will:

  • Have blood draws
  • Give urine samples
  • Have regular CT or MRI scans
  • Have other tests done during your clinic visits

Study Details

Full Title
An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumab as First-line Treatment for Subjects with HER2+ Metastatic Colorectal Cancer (SGNTUC-029; MOUNTAINEER-03)
Principal Investigator
Headshot of John Strickler
Professor of Medicine
Protocol Number
IRB: PRO00110153
NCT: NCT05253651
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL