. 2022 Sep 2;16:2933–2948. doi: 10.2147/DDDT.S380925

Table 3.

Phase II and III oral SERD trials in metastatic breast cancer

Trial	Oral SERD	Phase	N	ET line	Investigational Arm	Comparator Arm	Randomization	Primary Endpoint	Design	ClinicalTrials.gov
AMEERA-3	Amcenestrant	II	367^b	1–2	Amcenestrant 400mg	Physician’s choice ET (Fulvestrant, AI, Tamoxifen)	1:1	PFS	Open-label	NCT04059484
AMEERA-5	Amcenestrant	III	1068^b	1	Amcenestrant 200mg + Palbociclib^a	Letrozole + Palbociclib^a	1:1	PFS	Double-blind, placebo controlled	NCT04478266
persevERA	Giredestrant	III	978	1	Giredestrant 30mg + Palbociclib^a	Letrozole + Palbociclib^a	1:1	PFS	Double-blind, placebo controlled	NCT04546009
SERENA-4	Camizestrant	III	1342	1	Camizestrant 75mg + Palbociclib^a	Anastrozole + Palbociclib^a	1:1	PFS	Double-blind, placebo controlled	NCT04711252
SERENA-6	Camizestrant	III	302	1 (ESR1^mut ctDNA)	Camizestrant 75mg + Palbociclib/Abemaciclib^a	AI (letrozole/ anastrozole) + Palbociclib/Abemaciclib^a	1:1	PFS	Double-blind, placebo controlled	NCT04964934
EMBER-3	Imlunestrant	III	800	2 (prior AI alone or with CDK4/6i)	Imlunestrant 400mg vs Imlunestrant + Abemaciclib^a	Physician’s choice ET (fulvestrant/ exemestane)^a	1:1:1	PFS	Open-label	NCT04975308
SERENA-2	Camizestrant	II	240^b	2	Camizestrant75/150/300mg	Fulvestrant	1:1:1:1	PFS	Open-label	NCT04214288
EMERALD	Elacestrant	III	477^b	2–3, post CDK4/6i	Elacestrant 400mg	Physician’s choice ET (Fulvestrant/AI)	1:1	PFS in all patients and in ESR1^mut	Open-label	NCT03778931
acelERA	Giredestrant	II	303 ^b	2-3	Giredestrant 30mg	Physician’s choice ET (Fulvestrant/AI)	1:1	PFS	Open-label	NCT04576455

Notes: ^aAlso with luteinizing hormone releasing hormone agonist if premenopausal (or male in EMBER-3). ^bRecruitment completed.

Abbreviations: AI, aromatase inhibitor; ET, endocrine therapy; N, target enrolment; PFS, progression free survival; SERD, selective estrogen receptor degrader.