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Hope Rugo, MD, FASCO, University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, shares the safety outcome data from the Phase III monarchE trial (NCT03155997) of abemaciclib in combination with endocrine therapy in hormone receptor-positive, HER2-negative, high risk, early breast cancer. Primary trial analyses showed that the addition of abemaciclib to endocrine therapy in the adjuvant setting significantly improved invasive disease-free survival rates compared to endocrine therapy alone. Safety analyses found that 17.2% of patients discontinued abemaciclib due to adverse events, most of which occurred in the earliest months of treatment. Most adverse events were low grade and manageable with dose adjustments. The trial is ongoing and safety data collection continues. This interview took place during the 17th St. Gallen International Breast Cancer Conference.