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1 trials contain the search term(s): "NCT02614794"

Tucatinib with Xeloda & Herceptin to Treat Advanced HER2+ Breast Cancer

Pivotal Phase 2 Randomized, Double-Blinded, Controlled Study of ONT-380 vs Placebo in Combination With Capecitabine and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (NCT02614794)


Tucatinib (formerly ONT-380 or ARRY-380) is an investigational HER2-targeted therapy. Tucatinib is a small molecule that early studies suggest may be able to pass through the blood-brain barrier. This could make it an effective treatment for HER2+ breast cancer that has spread (metastasized) to the brain. Trastuzumab (Herceptin®) is a HER2-targeted therapy routinely used to treat HER2-positive breast cancer. Capacitabine (Xeloda®) is a chemotherapy drug used to treat metastatic breast cancer. This study is comparing the safety and effectiveness of tucatinib vs placebo, each in combination with Herceptin and Xeloda for patients with advanced HER2-positive breast cancer that has progressed on prior therapy.
This is a Phase II trial