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 29 | 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 |
|---|---|---|---|---|---|---|
| NCT05512364 | Phase III | Letrozole Anastrozole Exemestane Elacestrant Tamoxifen | Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA) (TREAT ctDNA) | Recruiting | ITA | FRA | DEU | BEL | 1 |
| 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) | Recruiting | USA | 4 |
| 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 |
| NCT05982093 | Phase II | Elacestrant Elacestrant + Triptorelin | Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer (SOLTI-2104) | Recruiting | ESP | 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) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | CAN | BEL | AUT | AUS | 8 |
| NCT04797728 | Phase I | Elacestrant | Elacestrant in Preoperative Setting, a Window of Opportunity Study (ELIPSE) | Completed | ESP | 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 | Not yet recruiting | USA | 0 |
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