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- SGNTUC-016: 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)
Clinical Trial
SGNTUC-016: 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 trial is studying tucatinib plus KADCYLAź (T-DM1) to find out what the side effects are and if it works for treating HER2 positive breast cancer. A side effect is anything the drug does to your body besides treating your disease. We do not yet know if tucatinib plus T-DM1 is better or worse than other treatments. Learning about the side effects of tucatinib plus T-DM1 and how it works will help us understand if tucatinib plus T-DM1 is better or worse than other treatments. To do this, we will compare 2 groups in this study. One group will get tucatinib plus T-DM1 and the other group will get a placebo plus T-DM1. A placebo is a pill that doesn?t have any drug or medicine in it. We will choose your group randomly, like tossing a coin.
Eligibility Criteria
- Confirmed HER2+ metastatic breast cancer, as determined by sponsor designated central laboratory testing on tumor tissue submitted prior to randomization History of prior treatment with a taxane and trastuzumab in any setting, separately or in combination. Prior pertuzumab therapy is allowed, but not required. HR (estrogen receptor [ER]/ progesterone receptor [PR]) status must be known prior to randomization Age 18 years or older at time of consent