Safety of Everolimus Plus Exemestane In Patients With Hormone-Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Progressing on Prior Non-Steroidal Aromatase Inhibitors: Primary Results of a Phase 3b, Open-Label, Single-Arm, Expanded-Access Multicenter Trial (BALLET)

This is the largest ever reported safety dataset on a general patient population presenting ABC treated with EVE plus EXE and included a sizeable elderly subset. This is also the first trial reporting the impact of BMI on safety. These data reinforce observations from the BOLERO-2 trial that the safety profile of everolimus plus exemestane was manageable; there were no new safety signals.

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