^
    5d
    A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=240, Recruiting, Stemline Therapeutics, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • First-in-human
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    Orserdu (elacestrant) • MEN2312
    20d
    UID 4270: The combination of Elacestrant and exemestane for patients with pretreated metastatic breast cancer expressing hormone receptors and non-expressing HER2, with lesions which uptake [18F]FES-avid (COMBINE): a proof-of-concept phase 2 clinical trial (2024-519792-25-00)
    P1/2, N=26, Not yet recruiting, Istituto Europeo Di Oncologia S.r.l.
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    exemestane • Orserdu (elacestrant)
    28d
    COMBINE-01: Elacestrant and Exemestane for Patients With Pretreated HR+/HER2- Metastatic Breast Cancer and [18F] FES-avid Lesions (COMBINE) (clinicaltrials.gov)
    P2, N=26, Not yet recruiting, European Institute of Oncology
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    exemestane • Orserdu (elacestrant)
    30d
    Real-World Evidence for 10 Oncology Drugs Approved in the last 5 years: A Comprehensive Narrative Synthesis. (PubMed, Crit Rev Oncol Hematol)
    RWE confirms the effectiveness and safety of multiple recently approved oncology drugs reinforcing the external validity of RCTs.
    Review • Journal • HEOR • Real-world evidence • MSi-H Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • MSI (Microsatellite instability)
    |
    HER-2 positive • MSI-H/dMMR • HER-2 negative • ESR1 mutation
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Lumakras (sotorasib) • Retevmo (selpercatinib) • Jemperli (dostarlimab-gxly) • Krazati (adagrasib) • Tepmetko (tepotinib) • Tabrecta (capmatinib) • Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv) • Orserdu (elacestrant)
    1m
    Characterization of In Vitro Metabolic Profiles of Elacestrant in Rat and Human Liver Microsomes Using HPLC-MS/MS and HPLC-Q-Orbitrap-HRMS. (PubMed, Biomed Chromatogr)
    Key metabolic pathways involved O-demethylation, N-deethylation, N-dealkylation, and oxidative deamination, primarily mediated by cytochrome P450 3A4. This study establishes the first HPLC-MS/MS and HPLC-Q-Orbitrap-HRMS-based analytical strategy for in vitro metabolic profiling of elacestrant, supporting its future application in clinical pharmacokinetic and metabolism investigations.
    Preclinical • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Orserdu (elacestrant)
    2ms
    PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) (clinicaltrials.gov)
    P2, N=297, Recruiting, Kristina A. Fanucci | Trial completion date: Oct 2029 --> Oct 2030 | Trial primary completion date: Dec 2028 --> Dec 2029
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CD4 (CD4 Molecule)
    |
    ER positive • HER-2 negative • ESR1 mutation • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
    |
    capecitabine • Orserdu (elacestrant)
    2ms
    PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) (clinicaltrials.gov)
    P2, N=297, Recruiting, Kristina A. Fanucci | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CD4 (CD4 Molecule)
    |
    ER positive • HER-2 negative • ESR1 mutation • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
    |
    capecitabine • Orserdu (elacestrant)
    2ms
    A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=240, Recruiting, Stemline Therapeutics, Inc. | Trial primary completion date: Oct 2025 --> Jun 2026
    Trial primary completion date • First-in-human
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    Orserdu (elacestrant) • MEN2312
    2ms
    Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer (clinicaltrials.gov)
    P2, N=24, Active, not recruiting, University of Miami | Recruiting --> Active, not recruiting | N=500 --> 24
    Enrollment closed • Enrollment change • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Lynparza (olaparib) • Ibrance (palbociclib) • everolimus • tamoxifen • Talzenna (talazoparib) • capecitabine • Piqray (alpelisib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • Halaven (eribulin mesylate) • Truqap (capivasertib) • letrozole • anastrozole • exemestane • Orserdu (elacestrant) • Navelbine oral (vinorelbine tartrate oral)
    2ms
    Elacestrant in metastatic breast cancer: current advancements and future perspectives. (PubMed, Expert Rev Anticancer Ther)
    With the growing integration of liquid biopsy technologies and molecular monitoring into clinical practice, dynamic treatment adaptation guided by real time molecular profiling is expected to refine therapy selection. Elacestrant is a benchmark in the shift toward individualized endocrine therapy in metastatic breast cancer, bridging molecular precision with clinical practicality.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    HR positive • HER-2 negative • ESR1 mutation • HR positive + HER-2 negative • HER-2 negative + HR positive + ESR1 mutation
    |
    Orserdu (elacestrant)
    3ms
    ADELA: Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. (clinicaltrials.gov)
    P3, N=240, Active, not recruiting, MedSIR | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 mutation
    |
    everolimus • dexamethasone • Orserdu (elacestrant)
    3ms
    POP-ELA: A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer (clinicaltrials.gov)
    P2, N=140, Recruiting, Gustave Roussy, Cancer Campus, Grand Paris | Not yet recruiting --> Recruiting
    Enrollment open
    |
    ER positive
    |
    Orserdu (elacestrant) • leuprolide acetate for depot suspension