Looking for participants

A phase III study evaluating tucatinib treatment with trastuzumab + mFOLFOX6 vs mFOLFOX6 treatment with or without cetuximab / bevacizumab in the first-line treatment of patients with metastatic HER2+ colorectal cancer (MOUNTAINEER-03)

We are studying tucatinib with trastuzumab and mFOLFOX6 to find out what side effects occur when they are administered together and whether the investigational drug is effective against colon or rectal cancer.

Aim of the study

Investigate tucatinib with trastuzumab and mFOLFOX6 to find out what side effects occur when they are given together and whether the investigational drug is effective against colorectal or rectal cancer.

Who can take part?

Histologically and/or cytologically proven adenocarcinoma of the colon or rectum that is locally advanced, inoperable or metastasized.

Procedure

After we have checked whether you are suitable for this study, we will assign you to a group (at random), just like tossing a coin. Your investigator will tell you which group you are in. One group will receive tucatinib with trastuzumab and mFOLFOX6. The other group will receive mFOLFOX6 alone and your investigator will decide whether you will also receive bevacizumab or cetuximab.

Compensation

Original study name

An unblinded, randomized, phase III study evaluating tucatinib treatment with trastuzumab plus mFOLFOX6 compared to mFOLFOX6 treatment with or without cetuximab or bevacizumab in the first-line treatment of patients with metastatic cancer.

BASEC number

2022-D0096

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