Prior pertuzumab treatment is permitted, but not required. This study is designed to evaluate the efficacy and safety of tucatinib in combination with T-DM1 in subjects with unresectable locally-advanced or metastatic HER2+ breast cancer who have had prior treatment with a taxane and trastuzumab in any setting. Patients will get T-DM1 injections from the study site staff on the first day of every cycle. Patients will swallow tucatinib pills or placebo pills two times every day. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. 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 (HER2CLIMB-02) ![]() Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
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