^
    7d
    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)
    7d
    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)
    8d
    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)
    15d
    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)
    18d
    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)
    24d
    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)
    26d
    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)
    27d
    Ph 2 Elacestrant in ER Positive Uterine Sarcomas (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Dana-Farber Cancer Institute
    New P2 trial
    |
    ER (Estrogen receptor)
    |
    Orserdu (elacestrant)
    28d
    WSG-AM16: 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) (2025-522484-15-00)
    P2/3, N=1050, Not yet recruiting, WSG Westdeutsche Studiengruppe GmbH
    New P2/3 trial
    |
    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
    |
    Kisqali (ribociclib) • Orserdu (elacestrant)
    1m
    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
    2ms
    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)
    2ms
    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)