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 25 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
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
NCT04797728 Phase I Elacestrant Elacestrant in Preoperative Setting, a Window of Opportunity Study (ELIPSE) Completed ESP 0
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
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
NCT05982093 Phase II Elacestrant Elacestrant + Triptorelin Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer (SOLTI-2104) Recruiting 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
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


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