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The trial that will decide whether HER2 drugs belong in the first treatment for HER2-positive bowel cancer rather than after chemotherapy has failed.
MOUNTAINEER-03 is the randomised phase 3 successor to the single-arm MOUNTAINEER cohorts that won tucatinib plus trastuzumab its accelerated approval on 19 January 2023. It randomises about 400 patients with previously untreated HER2-positive, RAS wild-type metastatic colorectal cancer to tucatinib and trastuzumab with mFOLFOX6, or to mFOLFOX6 with bevacizumab or cetuximab at the investigator's choice. The registry records a start date of 24 October 2022, recruitment continuing and primary completion due 31 December 2027, so the confirmatory evidence for the accelerated approval is several years away. Until then HER2-directed treatment in colorectal cancer is a later-line option and HER2 testing is not yet required at diagnosis everywhere.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares HER2 tyrosine kinase inhibitors, Tucatinib, HER2-amplified colorectal cancer, Trastuzumab.
Shares HER2 tyrosine kinase inhibitors, Tucatinib, Pfizer (incl. Seagen), Trastuzumab.
Shares HER2 tyrosine kinase inhibitors, Tucatinib, Pfizer (incl. Seagen), Trastuzumab.
Shares DESTINY-CRC02, MOUNTAINEER, HER2-amplified colorectal cancer, HER2.
Shares HER2 tyrosine kinase inhibitors, Tucatinib, Trastuzumab, Monoclonal antibodies.
Shares HER2 tyrosine kinase inhibitors, Tucatinib, Pfizer (incl. Seagen), Trastuzumab.
Shares MOUNTAINEER, HER2-amplified colorectal cancer, Trastuzumab, HER2.
Shares HER2 tyrosine kinase inhibitors, Tucatinib, Pfizer (incl. Seagen), Trastuzumab.
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