Table 1 Selected trials of novel estrogen receptor targeting drugs recruiting patients with HR + HER2− ABC (last updated August 2023).
Clinicaltrials.gov identifier | Phase | Drug | Drug class | Treatment arm(s) | Study population | Study status |
|---|---|---|---|---|---|---|
NCT04791384 | Ib/II | Elacestrant | SERD | Elacestrant + abemaciclib | Postmenopausal, HR+/HER2− MBC with brain metastasis, up to 2 lines of prior CT | Recruiting |
NCT05618613 (ELONA) | Ib/II | Elacestrant | SERD | Elacestrant + onapristone | Previously treated HR+/HER2− ABC with prior ET + CDK4/6i | Active, not recruiting |
NCT04546009 (PersevERA) | III | Giredestrant (GDC-9545) | SERD | Giredestrant + palbociclib Letrozole + palbociclib | Previously untreated HR+/HER2− ABC | Active, not recruiting |
NCT04802759 | Ib/II | Giredestrant | SERD | Giredestrant Giredestrant + abemaciclib Giredestrant + ipasertib Giredestrant + inavolisib Giredestrant + ribociclib Giredestrant + everolimus Giredestrant + samuraciclib Giredestrant + atezolizumab Giredestrant + abemaciclib + atezolizumab | Cohort 1: Advanced/MBC HR+/HER2− with progression on 1-2L ET + CDK4/6i | Recruiting |
NCT03616587 (SERENA-1) | I | Camizestrant (AZD9833) | SERD | Camizestrant Camizestrant + palbociclib Camizestrant + everolimus Camizestrant + abemaciclib Camizestrant + capivasertib Camizestrant + ribociclib Camizestrant + anastrozole | Endocrine-resistant HR+/HER2− ABC | Recruiting |
NCT04711252 (SERENA-4) | III | Camizestrant | SERD | Camizestrant + palbociclib Anastrozole + palbociclib | Untreated HR+/HER2− ABC | Recruiting |
NCT04964934 (SERENA-6) | III | Camizestrant | SERD | Camizestrant + CDK4/6i AI + CDK4/6i | HR+/HER2− ABC on 1L AI + CDK4/6i with ctDNA detected ESR1 mutation | Recruiting |
NCT04188548 (EMBER) | Ia/Ib | Imlunestrant (LY3484356) | SERD | Imlunestrant Imlunestrant + abemaciclib +/− AI Imlunestrant + everolimus Imlunestrant + alpelisib | Part A up to 1L therapy HR+/HER2− ABC, no CDK4/6i Part B HR+/HER2 ABC with prior CDK4/6i | Active, not recruiting |
NCT04975308 (EMBER-3) | III | Imlunestrant | SERD | Imlunestrant Imlunestrant + abemaciclib Physician’s choice ET (fulvestrant/exemestane) | Postmenopausal HR+/HER2− ABC with prior AI ± CDK4/6i | Recruiting |
NCT04568902 | I | H3B-6545 | SERCA | H3B-6545 | HR+/HER2− MBC with at least 2 prior ET, or 1 prior ET and 1 prior CT, or 1 prior ET + CDK4/6i | Active, not recruiting |
NCT04288089 | I | H3B-6545 | SERCA | H3B-6545 + palbociclib | Previously treated locally advanced/MBC HR+/HER2− | Active, not recruiting |
NCT04505826 | I/II | OP-1250 | CERAN | OP-1250 | Previously treated locally advanced/MBC HR+/HER2− | Active, not recruiting |
NCT05266105 | I | OP-1250 | CERAN | OP-1250 + palbociclib | HR+/HER2− ABC | Recruiting |
NCT05508906 | Ib | OP-1250 | CERAN | OP-1250 + ribociclib OP-1250 + alpelisib | Previously treated HR+/HER2− ABC with no more than 2L ET and 1L CT (prior CDK4/6i allowed) | Recruiting |
NCT04072952 | I/II | ARV-471 | PROTAC | ARV-471 ARV-471 + palbociclib | Previously treated (prior CDK4/6i allowed) postmenopausal MBC HR+/HER2− | Recruiting |
NCT05501769 | Ib | ARV-471 | PROTAC | ARV-471 + everolimus | Previously treated HR+/HER2− ABC with prior CDK4/6i | Recruiting |
NCT05654623 (VERITAC-2) | III | ARV-471 | PROTAC | ARV-471 Fulvestrant | Advanced/MBC HR+/HER2- with progression on ET + CDK4/6i, with at least 6 months of ET prior to PD | Recruiting |
NCT05573555 (TACTIVE-U) | Ib/II | ARV-471 | PROTAC | ARV-471 + ribociclib | Previously treated HR+/HER2− ABC with prior CDK4/6i, up to 2L prior therapies | Recruiting |
NCT05548127 (TACTIVE-U) | Ib/II | ARV-471 | PROTAC | ARV-471 + abemaciclib | Previously treated HR+/HER2− ABC with prior CDK4/6i in any setting | Recruiting |
