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HER2CLIMB/ ONT-380: Advanced HER2+ Breast Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study is to see if the study drug tucatinib works better than placebo to help people who have HER2 positive breast cancer.

What is the Condition Being Studied?

Advanced HER2+ Breast Cancer

Who Can Participate in the Study?

Adults who have HER2+ breast cancer and have gotten previous treatment with trastuzumab, pertuzumab, and T-DM1.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be randomized (like a flip of a coin) into one of two treatment groups:
-- Group 1 will get the study drug tucatinib, plus capecitabine and trastusumab.
-- Group 2 will get a placebo (a pill with no medicine), plus capecitebine and trastuzumab
- Have blood draws and physical exams during your regular office visits.

Study Details

Full Title
Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00067720
NCT:NCT02614794
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698