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Elacestrant Monotherapy VS. Standard of Care for the Treatment of Patients with ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-Label, Active-Controlled, Multicenter Trial (EMERALD)
This is an international, multicenter, randomized, open-label, active-controlled, event-driven, Phase 3 clinical study comparing the efficacy and safety of elacestrant to the SoC options of fulvestrant or an aromatase inhibitor (AI) in postmenopausal women and in men with advanced or metastatic ER+/HER2- breast cancer, either in subjects with tumors that harbor mutations in the ligand binding domain (LBD) of the estrogen receptor 1 (ESR1) gene (ESR1-mut subjects) or in all subjects regardless of ESR1 status (ESR1-mut and ESR1 wild type [ESR1-WT]) and whose disease has relapsed or progressed on at least one and no more than two prior lines of endocrine therapy (with documented progression), which must have included prior CDK4/6 inhibitor therapy in combination with fulvestrant or an aromatase inhibitor (AI) and for whom hormonal monotherapy with one of the SoC drugs (fulvestrant, anastrozole, letrozole, exemestane) is an appropriate treatment option.
Primary and Key Secondary Objectives Primary: To demonstrate that elacestrant compared with the SOC options of either fulvestrant or an AI is superior in prolonging PFS based on a blinded Imaging Review Committee (IRC) assessment in post-menopausal women and men with ER+/HER2- mBC, either in subjects with ESR1 mutations (ESR1-mut subjects) or in all subjects which includes subjects without detectable ESR1 mutations (ESR1-mut-nd) Key Secondary: To compare overall survival (OS) between treatment groups in ESR1-mut subjects. To compare OS between treatment groups in all subjects (ESR1-mut and ESR1-mut-nd)
Anastrozole (); Arimadex (Anastrozole); Aromasin (Exemestane); Elacestrant (); Exemestane (); Faslodex (fulvestrant); Femara (Letrozole); Letrozole (); fulvestrant ()