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
Phase of Trial: Phase III
Latest Information Update: 14 Dec 2018
At a glance
- Drugs Elacestrant (Primary) ; Anastrozole; Exemestane; Fulvestrant; Letrozole
- Indications Adenocarcinoma; Advanced breast cancer; Male breast cancer
- Focus Registrational; Therapeutic Use
- Acronyms EMERALD
- Sponsors Radius Health Inc.
- 30 Nov 2018 According to a Radius Health media release, the US. FDA recently granted Fast Track designation for the phase 3 study population (men and postmenopausal women with advanced ER+/HER2- breast cancer who have received at least 1 prior line of endocrine therapy, including prior cyclin-dependent kinase (CDK) 4/6 inhibitor therapy in combination with fulvestrant or an aromatase inhibitor).
- 30 Nov 2018 According to a Radius Health media release, depending on the results, this single trial is intended to support applications for marketing approvals for elacestrant as a second- and third-line monotherapy in the U.S., European Union, and other markets.
- 30 Nov 2018 Status changed from planning to recruiting, according to a Radius Health media release.