Table 2.
Ongoing Clinical Trials Examining the Use of Elacestrant in Breast Cancer
| Study | Study Setting | Study Population | Intervention | Primary Outcome(s) | Estimated Enrollment |
|---|---|---|---|---|---|
| ELIPSE: Elacestrant in Preoperative Setting, a Window of Opportunity Study (NCT04797728)23 | Early phase I | Post-menopausal women with ER-positive, HER2-negative breast cancer, stage cT1-3N0 | Elacestrant 400 mg PO daily for 4 weeks | Complete cell cycle arrest (Ki-67 ≤ 2.7%) | 23 patients |
| EORTC-2129-BCG: Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (NCT05512364)24 | Phase III | Pre- and post-menopausal women and men with high risk early-stage ER-positive, HER2-negative breast cancer | Elacestrant versus tamoxifen or AI | Distant metastasis free survival | 220 patients |
| ELECTRA: An Open-label Multicenter Phase 1b-2 Study of Elacestrant as Monotherapy and in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer (NCT05386108)25 | Phase Ib/II | Pre- and post-menopausal women and men with ER-positive and HER2-negative advanced breast cancer | Elacestrant as single agent and in combination with abemaciclib | Adverse events Efficacy of the combination of elacestrant with abemaciclib |
106 patients |
| ELEVATE: A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer (NCT05563220)26 | Phase Ib/II | Pre- and post-menopausal women and men with ER-positive and HER2-negative advanced breast cancer | Combination with alpelisib, everolimus, abemaciclib, ribociclib or palbociclib | Phase Ib: recommended phase 2 dose Phase II: PFS |
322 patients |
| Multicenter Open Label Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer (NCT04791384)27 | Phase Ib/II | Post-menopausal women with HR-positive and HER2-negative metastatic breast cancer with brain metastasis. Prior treatment with up to 2 lines of chemotherapy for advanced disease |
Elacestrant in combination with abemaciclib | Adverse effects Overall intracranial response rate and clinical benefit rate |
44 patients |
Abbreviations: ER-positive, estrogen receptor positive; HER2-negative, human epidermal growth factor receptor 2 negative; ctDNA, circulating tumor DNA; AI, aromatase inhibitor; HR-positive, hormone receptor positive.