^
    1d
    ELCIN: ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study (clinicaltrials.gov)
    P2, N=61, Active, not recruiting, Stemline Therapeutics, Inc. | Trial completion date: Jul 2027 --> Nov 2027 | Trial primary completion date: Jan 2026 --> Nov 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    Orserdu (elacestrant)
    2d
    Ph 2 Elacestrant in ER Positive Uterine Sarcomas (clinicaltrials.gov)
    P2, N=30, Recruiting, Dana-Farber Cancer Institute | Not yet recruiting --> Recruiting
    Enrollment open
    |
    ER (Estrogen receptor)
    |
    Orserdu (elacestrant)
    3d
    ADAPTela: Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- eBC (clinicaltrials.gov)
    P3, N=1520, Not yet recruiting, West German Study Group | N=1050 --> 1520
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    ER positive • HR positive • HER-2 negative • HER-2 negative + ER positive
    |
    MammaPrint® • Oncotype DX Breast Recurrence Score®Test
    |
    Kisqali (ribociclib) • Orserdu (elacestrant)
    9d
    BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=399, Recruiting, BeOne Medicines | N=300 --> 399 | Trial completion date: Jun 2028 --> Nov 2028 | Trial primary completion date: Jun 2028 --> Nov 2028
    Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    fulvestrant • letrozole • Orserdu (elacestrant)
    14d
    ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=65, Recruiting, Sarah Sammons, MD | Not yet recruiting --> Recruiting | Initiation date: Mar 2026 --> Nov 2025
    Enrollment open • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative • ESR1 mutation
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Orserdu (elacestrant)
    22d
    interACT: 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. (2025-523460-21-00)
    P1/2, N=159, Not yet recruiting, Centro Di Riferimento Oncologico Di Aviano
    New P1/2 trial • Liquid biopsy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • fulvestrant • Truqap (capivasertib) • Orserdu (elacestrant)
    23d
    Loss of luminal lineage drives resistance to next-generation ERα antagonists in pretreated ER+ HER2- locally-advanced or metastatic breast cancer. (PubMed, Nat Commun)
    In recent clinical trials of metastatic ER+ BC, next-generation SERDs demonstrated clinical activity, and elacestrant received an approval for advanced ESR1-mutant disease. NR tumors instead up-regulate multiple ERα-independent proliferative pathways, such as EGFR/MAPK and Hippo/TEAD, which may represent targetable dependencies in NR disease. Modeling resistance and lineage plasticity in vitro, we find that giredestrant-resistant ER+ BC cell lines exhibit profound shifts in chromatin accessibility, with the transcription factors, FOXA1 and FOXM1, implicated in gene expression of NR-upregulated proliferative pathways.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • FOXA1 (Forkhead Box A1) • FOXM1 (Forkhead Box M1)
    |
    ER positive • HER-2 negative • ESR1 mutation
    |
    Orserdu (elacestrant) • giredestrant (RG6171)
    24d
    Lilly-I3Y-US-I026: Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer (clinicaltrials.gov)
    P1/2, N=5, Terminated, Criterium, Inc. | N=44 --> 5 | Recruiting --> Terminated; Study was terminated due to delayed recruitment.
    Enrollment change • Trial termination
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    Verzenio (abemaciclib) • Orserdu (elacestrant)
    1m
    SUMIT-ELA: A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=49, Completed, Carrick Therapeutics Limited | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • CDK4 (Cyclin-dependent kinase 4)
    |
    TP53 mutation • ER positive • HER-2 negative • ESR1 mutation • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
    |
    Orserdu (elacestrant) • samuraciclib (CT7001)
    1m
    Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer (clinicaltrials.gov)
    P1/2, N=95, Recruiting, Ellipses Pharma | N=60 --> 95 | Trial completion date: Nov 2026 --> Feb 2028 | Trial primary completion date: Nov 2025 --> Feb 2028
    Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    everolimus • Verzenio (abemaciclib) • fulvestrant • exemestane • Orserdu (elacestrant) • vosilasarm (EP0062)
    1m
    A Computational Strategy to Identify Hub Genes in Pathway Analysis of Gamma Tocotrienol-treated MCF-7 Cells and Molecular Docking Study Using Selected Phytochemicals as Therapeutic Agents. (PubMed, Curr Med Chem)
    These findings may facilitate the development of traditional medicinebased therapeutic strategies and provide insights for potential lead optimization in breast cancer drug discovery.
    Journal
    |
    EGR1 (Early Growth Response 1)
    |
    Piqray (alpelisib) • Truqap (capivasertib) • Orserdu (elacestrant) • Legalon (silibinin)
    1m
    ADELA: Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. (clinicaltrials.gov)
    P3, N=240, Recruiting, MedSIR | Active, not recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation • ESR1 mutation
    |
    FoundationOne® CDx • Guardant360® CDx • FoundationOne® Liquid CDx
    |
    everolimus • dexamethasone • Orserdu (elacestrant)