ESMO 2022 | ELAINE 1: LAS vs fulv in la ER+/HER2- mBC ESR1m + disease progression on AI and CDK4/6i inhibitors

Shaheenah Dawood, MD, PhD, Dubai Hospital, Dubai, United Arab Emirates, discussesthe results of the Phase II ELAINE 1 (NCT03781063) trial. Preclinical models have indicated oral SERDs are superior to fulvestrant. Additionally the Phase III EMERALD (NCT03778931) trial had indicated a significant benefit with the oral SERDs in an investigation into elacestrant versus standard of care for the treatment of patients With ER+/HER2- advanced breast cancer. However, at the European Society for Medical Oncology (ESMO) 2022 Congress, two Phase II trials randomizing patients who had endocrine resistance disease to receive either an oral SERD or physicians choice of endocrine therapy showed no significant difference in progression-free survival (PFS) between the two treatments, although, when specifically looking at ESR1 population, a strong trend was observed favoring the oral SERD. The Phase ELAINE 1 trial investigated lasofoxifene versus fulvestrant for women with locally advanced/metastatic ER+/HER2- breast cancer, an ESR1 mutation, and disease progression on aromatase and cyclin-dependent kinase 4/6 (CDK4/6i) inhibitors. The trial demonstrated improved clinical outcomes with lasofoxifene. This interview took place at the European Society for Medical Oncology (ESMO) 2022 Congress in Paris, France.

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