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. Prior pertuzumab
treatment is permitted, but not required. Subjects will be randomized in a 1:1 manner to
receive 21-day cycles of either tucatinib or placebo in combination with T-DM1.
While on study treatment, subjects 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, subjects in both arms of the study will continue to be followed for
survival until study closure or withdrawal of consent.
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