Therapy Detail
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| Therapy Name | Elacestrant |
| Synonyms | |
| Therapy Description |
Orserdu (elacestrant) is a selective estrogen receptor degrader that down-regulates ER and ER-regulated genes, resulting in anti-tumor activity and may be effective in cells resistant to CDK4/6 inhibitors (PMID: 28473534, PMID: 31852484). Orserdu (elacestrant) is FDA approved for use in postmenopausal women or adult men with ER-positive, ERBB2 (HER2)-negative, ESR1 (ER alpha)-mutated advanced or metastatic breast cancer progressed on endocrine therapy (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Elacestrant | Orserdu | RAD1901 | Hormone - Anti-estrogens 31 | Orserdu (elacestrant) is a selective estrogen receptor degrader that down-regulates ER and ER-regulated genes, resulting in anti-tumor activity and may be effective in cells resistant to CDK4/6 inhibitors (PMID: 28473534, PMID: 31852484). Orserdu (elacestrant) is FDA approved for use in postmenopausal women or adult men with ER-positive, ERBB2 (HER2)-negative, ESR1 (ER alpha)-mutated advanced or metastatic breast cancer progressed on endocrine therapy (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05596409 | Phase II | Elacestrant | ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study (ELCIN) | Active, not recruiting | USA | ROU | BRA | BGR | 2 |
| NCT05512364 | Phase III | Letrozole Anastrozole Exemestane Elacestrant Tamoxifen | Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA) (TREAT ctDNA) | Recruiting | SWE | NLD | ITA | IRL | GRC | FRA | ESP | DEU | CYP | CHE | BEL | 0 |
| NCT07159451 | Phase II | Elacestrant + Leuprolide Elacestrant | A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer (POP-ELA) | Recruiting | FRA | 0 |
| NCT06062498 | Phase II | Abemaciclib + Elacestrant Elacestrant Elacestrant + Palbociclib Elacestrant + Ribociclib | Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer | Recruiting | USA | 0 |
| NCT02338349 | Phase I | Elacestrant | A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer | Completed | USA | 0 |
| NCT06492616 | Phase III | Exemestane Elacestrant Tamoxifen Letrozole Anastrozole | A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence (ELEGANT) | Recruiting | USA | TUR | ROU | POL | NLD | ITA | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG | 6 |
| NCT06923527 | Phase II | Elacestrant | Circulating Tumor DNA | Recruiting | USA | 0 |
| NCT03778931 | Phase III | Letrozole Exemestane Elacestrant Fulvestrant Anastrozole | Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer (EMERALD) | Completed | USA | ITA | ISR | IRL | HUN | GRC | GBR | FRA | ESP | DNK | CAN | BEL | AUT | AUS | ARG | 2 |
| NCT05982093 | Phase II | Elacestrant Elacestrant + Triptorelin | Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer (SOLTI-2104) | Active, not recruiting | ESP | 0 |
| NCT07005882 | Phase II | Elacestrant | Hormonal Receptor (HR)-Positive HER2 Negative Breast Cancer Patients Treated With Preoperative ELacestrant and PULSAR Radiotherapy (HELP) | Not yet recruiting | ITA | 0 |
| NCT07209449 | Phase II | Elacestrant Abemaciclib + Elacestrant | A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer | Recruiting | USA | 0 |
| NCT07222215 | Phase II | Capecitabine + Elacestrant Capecitabine Elacestrant | PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) (CAPELA) | Not yet recruiting | USA | 0 |
| NCT04797728 | Phase I | Elacestrant | Elacestrant in Preoperative Setting, a Window of Opportunity Study (ELIPSE) | Completed | ESP | 0 |
| NCT06382948 | Phase III | Elacestrant Elacestrant + Everolimus | Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. (ADELA) | Recruiting | ITA | GRC | GBR | FRA | ESP | DEU | CZE | AUT | 0 |
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