Impact of COVID-19
Enrollment began in February 2020 but was slower than expected because of the COVID-19 pandemic. To minimize delay in the clinical development of amcenestrant, an unplanned administrative interim analysis was performed after 63 study participants had been randomized. This analysis, which included 55 evaluable participants, provided pharmacodynamic and safety data that were deemed sufficient to enable the strategic development decisions for which AMEERA-4 had been designed and did not change the benefit-risk profile of amcenestrant. Consequently, the decision was taken to terminate the trial before it was fully enrolled.As a result of early termination of the trial, no formal statistical inferences were conducted; only descriptive statistics were provided.