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MOUNTAINEER: Tucatinib for HER2+ Colorectal Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to look at the effects (good and/or bad) of taking study drugs Tucatinib and Trastuzumab has on you and your metastatic colorectal cancer.

What is the Condition Being Studied?

Metastatic Colorectal Cancer

Who Can Participate in the Study?

Adults who:
- Are diagnosed with metastatic colorectal cancer
- Have a positive test for HER2 overexpression or amplification
- Have not been treated with anti-HER2 therapy

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Get the study drugs tucatinib and trastuzumab
-- Tucatinib is given by mouth twice a day and trastuzumab is given into your arm the first day of every 21 days in the clinic at Duke
-- This cycle will be repeated until your cancer gets worse or you have bad side effects or you choose to stop the study for any reason.
- Have tests, exams and procedures that are part of your standard of care and for study purposes. Clinic visits will usually last 4-5 hours

Study Details

Full Title
A Phase II, Open Label Study of Tucatinib Combined with Trastuzumab in Patients with HER2+ Metastatic Colorectal Cancer
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00082879
NCT:NCT03043313
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698