^
    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, Recruiting, West German Study Group | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • HER-2 negative + ER positive
    |
    MammaPrint® • Oncotype DX Breast Recurrence Score®Test
    |
    Orserdu (elacestrant)
    5d
    ELENI: Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P=N/A, N=500, Not yet recruiting, iOMEDICO AG
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Orserdu (elacestrant)
    10d
    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
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • HER-2 negative + ER positive
    |
    MammaPrint® • Oncotype DX Breast Recurrence Score®Test
    |
    Orserdu (elacestrant)
    16d
    SOLTI-2104: Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer (clinicaltrials.gov)
    P2, N=96, Recruiting, SOLTI Breast Cancer Research Group | Active, not recruiting --> Recruiting | N=48 --> 96 | Trial completion date: Feb 2026 --> Dec 2026 | Trial primary completion date: Jun 2025 --> Dec 2026
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • HER-2 expression • HER-2 negative + ER positive
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    tamoxifen • Orserdu (elacestrant) • triptorelin
    17d
    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)
    18d
    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)
    19d
    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)
    25d
    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)
    1m
    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)
    1m
    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)
    1m
    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)
    1m
    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)