Table 1.
Ongoing Trials: Numerous nonsteroidal SERDs are now being studied in clinical trials. Here we summarize the orally available SERDs currently in clinical development.
| AGENT | TREATMENT | DISEASE SETTING | PHASE | NAME (INDICATOR) |
|---|---|---|---|---|
| SERMs | ||||
| LASOFOXIFENE | vs. FULVESTRANT +ABEMACICLIB |
Previously treated advanced/metastatic disease with
ESR1
mutations Previously treated advanced/metastatic disease with ESR1 mutations |
2 2 |
ELAINE: NCT03781063 ELAINE 2: NCT04432454 |
| BAZEDOXIFENE | +PALBOCICLIB | Previously treated advanced/metastatic | 1/2 | NCT02448771 |
| SERDs | ||||
| LSZ102 | SINGLE AGENT/+ RIBOCICLIB/+ ALPELISIB |
Previously treated advanced/metastatic | 1/1b | NCT02734615 |
| G1T48 (RINTODESTRANT) |
SINGLE AGENT+/− PALBOCICLIB |
Previously treated advanced/metastatic | 1 | NCT03455270 |
| RAD1901 (ELACESTRANT) |
vs. SOC (standard of care) | Previously treated advanced/metastatic | 3 | EMERALD: NCT03778931 |
| GDC-9545 (GIREDESTRANT) |
GDC-9545 vs. LETROZOLE + PALBOCICLIB GDC-9545 vs. ANASTROZOLE + PALBOCICLIB vs. physician’s choice of endocrine therapy +/− PALBOCICLIB and LHRH agonist Monotherapy |
Advanced/metastatic Treatment-naïve early breast cancer (window-of-opportunity -> neoadjuvant) Previously treated advanced/metastatic Advanced/metastatic Treatment-naïve early breast cancer (window-of-opportunity) |
3 2 2 1 1 |
persevERA: NCT04546009 coopERA: NCT04436744 acelERA: NCT04576455 NCT03332797 NCT03916744 |
| SAR439859 (AMCENESTRANT) |
SAR439859 vs. LETROZOLE + PALBOCICLIB vs. physician’s choice of endocrine therapy vs. LETROZOLE +/− PALBOCICLIB OR ALPELISIB |
Advanced/metastatic Previously treated advanced/metastatic Newly diagnosed advanced/metastatic Advanced/metastatic |
3 2 2 1/2 |
AMEERA-5: NCT04478266 AMEERA-3: NCT04059484 AMEERA-4: NCT04191382 AMEERA-1 NCT03284957 |
| AZD9833 (CAMIZESTRANT) |
AZD9833 vs. LETROZOLE + PALBOCICLIB MONOTHERAPY vs. FULVESTRANT +/− PALBOCICLIB, EVEROLIMUS OR ABEMACICLIB |
Treatment-naïve advanced/metastatic Neoadjuvant treatment Previously treated advanced/metastatic Previously treated advanced/metastatic |
3 2 2 1 |
SERENA-4: NCT04711252 SERENA-3: NCT04588298 SERENA-2: NCT04214288 SERENA-1: NCT03616587 |
| LY3484356 | +/− other anticancer therapies MONOTHERAPY |
Advanced/metastatic Neoadjuvant treatment |
1 1 |
EMBER: NCT04188548 EMBER 2: NCT04647487 |
| Zn-c5 | SINGLE AGENT +/− PALBOCICLIB |
Previously treated advanced/metastatic | 1/2 | NCT03560531 |
| D-0502 | SINGLE AGENT +/− PALBOCICLIB |
Previously treated advanced/metastatic | 1 | NCT03471663 |
| NOVEL THERAPIES |
||||
| ARV-471 (PROTAC) | +/− PALBOCICLIB | Previously treated advanced/metastatic | 1/2 | NCT04072952 |
| H3B-5942 (SERCA) | MONOTHERAPY + PALBOCICLIB |
Previously treated advanced/metastatic Previously treated advanced/metastatic |
1/2 1 |
NCT03250676 NCT04288089 |
Abbreviations: ORR: overall response rate; CBR: clinical benefit rate; PFS: progression-free survival; AEs: adverse events; AAT: aspartate aminotransferase; DLT: dose-limiting toxicities; SD: stable disease.