Operational Metrics for the ELAINE 2 Study Combining a Traditional Approach With a Just-in-TIME Model.

Purpose: There are numerous barriers to enrollment in oncology biomarker-driven studies.

Methods: The ELAINE 2 study (ClinicalTrials.gov identifier: NCT04432454) is an open-label phase 2 study of lasofoxifene combined with abemaciclib in patients with advanced or metastatic estrogen receptor-positive/human epidermal growth factor receptor 2-negative breast cancer with an mutation.