ADELA: Expanding Options for ESR1- Mutated Breast Cancer

In this video, Dr Antonio Llombart-Cussac, medical oncologist at the University hospital Arnau de Vilanova in Lleida, Spain explains the design and objectives of the randomized, phase III ADELA trial to Prof Dr François Duhoux. ADELA is an international, multicenter, phase 3, randomized, double-blind, placebo-controlled trial. To be eligible for the study, patients need to have an oestrogen receptor positive (ER+), HER2- advanced breast cancer and harbor an ESR1-mutation. Patients must be previously treated with at least one and no more than two lines of endocrine therapy in the advanced setting, including a CDK4/6 inhibitor (CDK4/6i). Patients will be randomized 1:1 to 28-day cycles of oral elacestrant 345 mg + everolimus 7.5 mg QD or elacestrant 345 mg + placebo QD until disease progression or unacceptable toxicity. Stratification factors include the presence of visceral metastases and the duration of prior CDK4/6i-based therapy. The primary endpoint of ADELA is progression-free survival (PFS) assessed by the blinded independent review committee (BIRC). Secondary objectives include investigator-assessed PFS and overall survival (OS), BIRC- and investigator-assessed response rate, clinical benefit rate and time to response. Furthermore, the study will also look at quality of life and will try to identify biomarkers.