Table Info

Table 2.

Identifier, interventions, outcome measures, participants, completion date and locations of ongoing/unreported trials

No.	NCT	Title	Status	Conditions	Interventions	Outcome measures	Phase	N	Study Design	Completion Date	Collaborators	Locations
1	NCT05596409	ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study (ELCIN)	Not yet recruiting	Metastatic breast cancer	Elacestrant	PFS; ORR; DOR; clinical benefit rate; PFS; OS	2	80	Single group, open label, interventional	August, 2025	Stemline Therapeutics, Inc.	United States
2	NCT05563220	Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer (ELEVATE)	Recruiting	Breast cancer; metastatic breast cancer	Elacestrant; alpelisib; everolimus; ribociclib; palbociclib	RP2D; safety; pharmacokinetic assessment profile; ORR; DOR; clinical benefit rate; PFS; OS	1 & 2	322	Non-randomized, parallel assignment, open label, interventional	August, 2026	Stemline Therapeutics, Inc.	United States
3	NCT05618613	Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer (ELONA)	Active, not recruiting	Breast cancer	Elacestrant; onapristone	RP2D; ORR per RECIST version 1.1.; AE, SAE, changes in clinical laboratory values; vital sign measurements; changes in ECG parameters; area under the plasma concentration-time curve over the dosing interval; Cmax, Tmax; trough concentration; clinical benefit rate; PFS; OS	1 & 2	67	Single group, open label, interventional	April, 2026	Context Therapeutics Inc.	United States
4	NCT04791384	Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer	Recruiting	Breast cancer	Abemaciclib; elacestrant	AE; efficacy of the combination abemaciclib and elacestrant; tumor response rates; duration of tumor response rates; completion rate	1 & 2	44	Sequential assignment, open label, interventional	June, 2023	Criterium, Inc.	United States
5	NCT05512364	TREAT ctDNA Elacestrant	Not yet recruiting	ER+ breast cancer; HER2– breast cancer; stage IIB breast cancer; stage III breast cancer	Elacestrant; tamoxifen; letrozole 2.5 mg; anastrozole 1 mg; exemestane 25 mg	DMFS; ctDNA elimination rate at month 1	3	220	Randomized, parallel assignment, open label, interventional	May, 2030	European Organisation for Research and Treatment of Cancer - EORTC; Breast International Group; Menarini Group	Belgium, Greece
6	NCT05386108	Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/HER2- Breast Cancer (ELECTRA)	Recruiting	Breast neoplasms; breast diseases	Elacestrant; abemaciclib	RP2D; ORR; intracranial response rate per RECIST; intracranial response rate per RANO; duration of tumor response; clinical benefit rate; duration of PFS	1 & 2	106	Non-randomized, sequential assignment, open label, interventional	December, 2025	Stemline Therapeutics, Inc.	United States, Korea, Spain
7	NCT04797728	Elacestrant in Preoperative Setting, a Window of Opportunity Study (ELIPSE)	Completed	Breast cancer; hormone receptor positive breast carcinoma	Elacestrant	Complete cell cycle arrest; PAM50 (prediction analysis of microarray 50) subtype change; gene expression change; AE; global gene expression changes; gene expression-based signature of response; CelTIL score; mean change in Ki67; changes in the distribution of somatic mutations; ctDNA	Early, 1	23	Single group, open label, interventional	February, 2022	SOLTI Breast Cancer Research Group; Radius Health, Inc.	Spain

AE: adverse events; OS: overall survival; PFS: progression-free survival; RP2D: recommended phase 2 dose; ORR: objective response rate; HER2–: HER2-negative; ER+: estrogen receptor-positive

Declarations

Author contributions

AS: Conceptualization, Methodology, Project administration, Supervision, Writing—original draft, Writing—review & editing. MS: Conceptualization, Methodology, Project administration, Supervision, Writing—original draft, Writing—review & editing. FJ: Validation, Writing—original draft, Writing—review & editing. MK: Data curation, Investigation, Writing—original draft, Writing—review & editing. BS: Writing—original draft, Writing—review & editing. AG: Writing—original draft, Writing—review & editing. MAG: Formal analysis, Software, Writing—original draft, Writing—review & editing. AI: Writing—original draft, Writing—review & editing. KC: Supervision, Visualization, Writing—original draft, Writing—review & editing.

Conflicts of interest

The authors declare no conflicts of interest.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

All data utilized for the purpose of this study are available publicly and online.

Funding

Not applicable.

Copyright

Publisher’s note

Open Exploration maintains a neutral stance on jurisdictional claims in published institutional affiliations and maps. All opinions expressed in this article are the personal views of the author(s) and do not represent the stance of the editorial team or the publisher.

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