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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 (HER2CLIMB-02)
This study is designed to evaluate the efficacy and safety of tucatinib in combination with 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. Prior pertuzumab treatment is permitted, but not required. Patients will be randomized in a 1:1 manner to receive 21-day cycles of either tucatinib or placebo in combination with T-DM1.
This study will evaluate the efficacy and safety of tucatinib versus placebo in combination with T-DM1 in subjects with unresectable locally-advanced or metastatic (LA/M) HER2+ breast cancer.
Trastuzumab emtansine (); Tucatinib ()