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Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer
This study is designed to evaluate the efficacy and safety of tucatinib in combination with Ado-trastuzumab Emtansine (T-DM1) in patients with unresectable locally-advanced or metastatic HER2+ breast cancer who have had prior treatment with a taxane and trastuzumab in any setting. Eligible patients will be randomised to receive 21-day cycles of either tucatinib or placebo in combination with T-DM1. While on study treatment, patients will be assessed for progression every 6 weeks for the first 24 weeks, and every 9 weeks thereafter, irrespective of dose holds or interruptions. Study treatment will continue until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. After completion of study treatment and after occurrence of disease progression, patients in both arms of the study will continue to be followed for survival until study closure or withdrawal of consent.