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.
Who Can Participate?
Eligibility
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
What is Involved?
Description
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.
- 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
John
Strickler
Protocol Number
PRO00110153
NCT ID
NCT05253651
Phase
III
Enrollment Status
Open to Enrollment