Table 1.
Completed and ongoing clinical trials of oral selective estrogen receptor degraders (SERDs)
| Drug name | Study drugs | Trial name/NCT No | Companies | Phase | Primary outcome | Status |
|---|---|---|---|---|---|---|
| Elacestrant (GS2-02 and RAD 1901) | Elacestrant, fulvestrant, anastrozole, letrozole, exemestane | EMERALD | Radius | Phase III | PFS | Active, not recruiting |
| Amcenestrant (SAR439859) | Amcenestrant, fulvestrant, anastrozole, letrozole, exemestane, tamoxifen | AMEERA-3 | Sanofi | Phase II | PFS | Completed |
| Amcenestrant (SAR439859) | SAR439859, palbociclib letrozole, goserelin | AMEERA-5 | Sanofi | Phase III | PFS | Completed |
| Amcenestrant (SAR439859) | Amcenestrant, tamoxifen | AMEERA-6 | Sanofi | Phase III | Invasive breast cancer–free survival (IBCFS) | Discontinued |
| Camizestrant (AZD9833) | AZD9833 + CDK4/6 inhibitor | SERENA-6 | AstraZeneca | Phase III | PFS | Recruiting |
| Camizestrant (AZD9833) | AZD9833 plus palbociclib versus anastrozole plus palbociclib | SERENA-4 | AstraZeneca | Phase III | PFS | Recruiting |
| Giredestrant (GDC9545) | Giredestrant | NCT04961996 | Hoffmann-La Roche | Phase III | Invasive disease-free survival (IDFS) | Recruiting |
| Giredestrant (GDC9545) | Giredestrant, letrozole, palbociclib, LHRH agonist | NCT04546009 | Hoffmann-La Roche | Phase III | PFS | Recruiting |
| Giredestrant (GDC9545) | Giredestrant, fulvestrant or an aromatase inhibitor (physician’s choice), LHRH agonist | acelERA | Roche | Phase II | PFS | Completed |
| Imlunestrant (ly3484356) | LY3484356 exemestane fulvestrant | EMBER-3 | Eli Lilly | Phase III | PFS | Not yet recruiting |
| Rintodestrant (G1T148) | G1T48 palbociclib | NCT03455270 | G1 Therapeutics, Inc | Phase I | Dose-limiting toxicity (DLT) | Active, not recruiting |
| SHR9549 | SHR9549 | NCT03596658 | Jiangsu HengRui Medicine Co., Ltd | Phase I | Dose limited toxicity (DLT) | Unknown |
| ZN-c5 | ZN-c5 palbociclib | NCT03560531 | Zeno Alpha | Phase I Phase II | Determine a maximum tolerated dose (MTD) or recommended phase II dose (RP2D) for ZN-c5 as a monotherapy | Recruiting |
| D-0502 | D-0502 and in combination with palbociclib | NCT03471663 | InventisBio | Phase I | Incidence of AEs meeting protocol-defined dose-limiting toxicities (DLTs) criteria | Recruiting |
CDK4/6, cyclin-dependent kinase 4/6; SERD, selective estrogen receptor degrader; NCT, national clinical trial; PFS, progression-free survival