eMonarcHER: A Randomized Double Blind Placebo-Controlled Phase 3 Study of Abemaciclib plus Standard Adjuvant Endocrine Therapy in Participants with High-Risk Node-Positive HR+ HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy
Brief description of study
The purpose of the study is to determine and compare the efficacy of abemaciclib plus physician’s choice ET (endocrine therapy) versus placebo plus physician’s choice ET in the study population. Participants will be assigned to blinded study drug (either the abemaciclib or placebo treatment arm) plus ET. Study intervention will be given for up to 26 cycles, approximately 2 years, or until evidence of disease recurrence or another discontinuation criterion is met, whichever occurs first. The study drug abemaciclib is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.
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