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A Phase lb/ll, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Venetoclax in Combination With Trastuzumab Emtansine in Patients With Previously Treated HER2-Positive Locally Advanced or Metastatic Breast Cancer
This is a dose escalation and expansion study, containing two phases. The first phase will be used to determine the maximum tolerated and recommended phase 2 dose (RP2D) of trastuzumab emtansine, which participants will receive intravenously in combination with oral venetoclax. The second phase will compare the safety, efficacy, tolerability, and pharmacokinetics of trastuzumab emtansine in combination with venetoclax at the RP2D, compared with trastuzumab emtansine alone, in which patients will either receive venetoclax or a placebo.