ORSERDU 345 mg film-coated tablets
Sponsors
Stemline Therapeutics Inc., Carrick Therapeutics Limited, Verein Zur Praevention Und Therapie Boesartiger Erkrankungen Austrian Breast And Colorectal Cancer Study Group, Ellipses Pharma Limited, Medica Scientia Innovation Research S.L., Medica Scientia Innovation Research S.L., Stemline Therapeutics Inc.
Conditions
Breast CancerER+/HER2- early breast cancerESR1-mutatedMetastatic breast canceradvanced breast cancer progressing to endocrine therapy
and CDK4/6 inhibitors.endocrine-responsive HER2-negative early breast cancermetastatic breast cancerpatients with estrogen receptor-positive/human epidermal growth factor
receptor 2-negative
Phase 1
A Phase 1b/2 Open-Label Study of Samuraciclib in Combination with Elacestrant in Participants with Metastatic or Locally Advanced Hormone-Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer
Active, not recruitingCTIS2023-503846-30-00
Start: 2023-10-10Target: 48Updated: 2026-01-27
A Modular Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimisation, and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 as monotherapy and in combination in Patients with Relapsed Locally Advanced or Metastatic AR+/HER2-/ER+ Breast Cancer
RecruitingCTIS2023-507738-26-00
Start: 2024-03-20Target: 25Updated: 2025-10-02
Phase 2
Elacestrant in women and men with CDK4/6 Inhibitor-Naïve estrogen receptor positive, HER2 negative metastatic breast cancer: An open-label multicenter phase 2 study (ELCIN)
Active, not recruitingCTIS2023-503214-68-00
Start: 2024-01-31Target: 30Updated: 2025-06-23
ABCSG 63 / ERIKA: Elacestrant and RIbociclib in Ki67-tested endocrine responsive breAst cancer: An open-label, two-arm, randomized, phase II study of elacestrant plus ribociclib vs. AI (plus GnRH agonist in pre-/perimenopausal women and men) plus ribociclib as neoadjuvant therapy for endocrine-responsive HER2-negative early breast cancer
RecruitingCTIS2023-505758-17-00
Start: 2025-08-21Target: 120Updated: 2025-12-10
A multicenter, multicohort, phase 2 platform trial to personalize second-line treatment intensity and targeting in HR-positive, HER2-negative metastatic breast cancer through an integrated liquid biopsy algorithm.
Not yet recruitingCTIS2025-523460-21-00
Target: 159Updated: 2026-03-31
Phase 3
A randomized phase 3, double-blind, placebo-controlled study of elacestrant plus everolimus versus elacestrant in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced breast cancer progressing to endocrine therapy and CDK4/6 inhibitors - The ADELA study-
RecruitingCTIS2024-512926-27-00
Start: 2024-12-12Target: 214Updated: 2025-02-13
Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing adjuvant Elacestrant with standard endocrine treatment in genomically and/or clinically high-risk ER+/HER2- early breast cancer (ADAPTela)
Not yet recruitingCTIS2025-522484-15-00
Target: 1050Updated: 2026-03-11