Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer


About this study

The purpose of this study is to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable). 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum
which is metastatic and/or unresectable

- Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE)
tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment
initiation to a central laboratory

- If archival tissue is not available, a newly-obtained baseline biopsy of an
accessible tumor lesion is required within 35 days prior to start of study

- HER2+ disease as determined by a tissue based assay performed at a central laboratory.

- Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as
determined by local or central testing

- Radiographically measurable disease per RECIST v1.1 with:

- At least one site of disease that is measurable and that has not been previously
irradiated, or

- If the participant has had previous radiation to the target lesion(s), there must
be evidence of progression since the radiation

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may
have any of the following:

- No evidence of brain metastases

- Previously treated brain metastases which are asymptomatic

Exclusion Criteria:

- Prior systemic anticancer therapy for colorectal cancer (CRC) in the metastatic

- May have received chemotherapy for CRC in the adjuvant setting if it was
completed >6 months prior to enrollment

- Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting
of stereotactic radiosurgery)

- Previous treatment with anti-HER2 therapy

- Ongoing Grade 3 or higher neuropathy

- GI perforation within 12 months of enrollment

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Joleen Hubbard, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Tanios Bekaii-Saab, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions