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:<ul>
<li>Have HER2+ mutation</li>
<li>Able to swallow oral medication</li>
<li>Have not had prior systemic anticancer therapy for colorectal cancer (CRC) in the metastatic setting</li></ul>
For more information about who can join this study, please contact the study team at sabina.wlazlo@duke.edu.
<li>Have HER2+ mutation</li>
<li>Able to swallow oral medication</li>
<li>Have not had prior systemic anticancer therapy for colorectal cancer (CRC) in the metastatic setting</li></ul>
For more information about who can join this study, please contact the study team at sabina.wlazlo@duke.edu.
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:<ul>
<li>Group 1 will take tucatinib pills, mFOLFOX6 will be given into a vein (intravenous, "IV"), and trastuzumab will be given by IV.</li>
<li>Group 2 will get mFOLFOX6 by IV and bevacizumab by IV.</li></ul>
Participants in both groups will:<ul>
<li>Have blood draws</li>
<li>Give urine samples</li>
<li>Have regular CT or MRI scans</li>
<li>Have other tests done during your clinic visits</li></ul>
<li>Group 1 will take tucatinib pills, mFOLFOX6 will be given into a vein (intravenous, "IV"), and trastuzumab will be given by IV.</li>
<li>Group 2 will get mFOLFOX6 by IV and bevacizumab by IV.</li></ul>
Participants in both groups will:<ul>
<li>Have blood draws</li>
<li>Give urine samples</li>
<li>Have regular CT or MRI scans</li>
<li>Have other tests done during your clinic visits</li></ul>
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