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

ONT-380 with Xeloda & Herceptin to Treat Advanced HER2+ Breast Cancer

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)

Summary

ONT-380 (formerly ARRY-380) is an investigational HER2-targeted therapy. ONT-380 is a small molecule that early studies suggest may be 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 ONT-380, Herceptin and Xeloda with Herceptin, Xeloda and a placebo in patients with advanced HER2-positive breast cancer that has progressed on prior therapy.
This is a Phase II trial