^
    1d
    Standardized Analytical Verification of ctDNA ESR1 Mutation Testing in Metastatic HR+/HER2- Breast Cancer: A European Multicentre Study Using dPCR and NGS-Based Liquid Biopsy. (PubMed, Mol Diagn Ther)
    These results demonstrate that both dPCR and NGS-based liquid biopsy workflows can be successfully implemented for ESR1 mutation testing in routine clinical practice using locally validated assays. This multicentre verification study provides practical guidance on assay verification, DNA input requirements, and key analytical parameters required to ensure reliable ESR1 mutation detection across different European laboratories. Robust analytical verification of ESR1 testing may improve diagnostic reliability and support personalized treatment strategies for patients with hormone receptor-positive, HER2-negative metastatic breast cancer.
    Journal • Liquid biopsy • Next-generation sequencing • Circulating tumor DNA
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HR positive • HER-2 negative • HER-2 mutation • ESR1 mutation • HR positive + HER-2 negative • HER-2 negative + HR positive + ESR1 mutation
    |
    Orserdu (elacestrant)
    6d
    ELEVATE: Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=435, Active, not recruiting, Stemline Therapeutics, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    PIK3CA mutation
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    Ibrance (palbociclib) • everolimus • Piqray (alpelisib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • Truqap (capivasertib) • Orserdu (elacestrant)
    9d
    Elacestrant With Everolimus for the Treatment of Recurrent Advanced or Metastatic ER-Positive Endometrial Cancer (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Jonsson Comprehensive Cancer Center
    New P2 trial
    |
    ER (Estrogen receptor)
    |
    MSI-H/dMMR
    |
    everolimus • Orserdu (elacestrant)
    17d
    ESR1 mutations in ER-positive breast cancer: from endocrine resistance to ctDNA-guided therapeutic interception. (PubMed, Explor Target Antitumor Ther)
    The regulatory approval of elacestrant for ESR1-mutant disease and randomized trial data showing progression-free survival (PFS) benefit from ctDNA-guided endocrine switching (PADA-1, SERENA-6) position ESR1 genotyping as a dynamic biomarker with direct therapeutic implications...The convergence of structural mechanisms, liquid biopsy technology, and biomarker-driven drug development provides a framework for precision oncology in endocrine-resistant breast cancer. While these advances are substantial, important challenges remain, including the lack of mature overall survival (OS) data from interception trials, cost and accessibility barriers to serial ctDNA monitoring in diverse global healthcare settings, the unresolved question of optimal therapeutic sequencing in patients with concurrent ESR1 and PI3K pathway alterations, and the need to distinguish clinically actionable low-variant allele frequency (VAF) ESR1 calls from background noise in liquid biopsies.
    Review • Journal • Circulating tumor DNA
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    ER (Estrogen receptor)
    |
    ER positive • ESR1 mutation
    |
    Orserdu (elacestrant)
    21d
    Elacestrant in Advanced Triple Positive Breast Cancer (clinicaltrials.gov)
    P1/2, N=50, Recruiting, NYU Langone Health
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Orserdu (elacestrant)
    27d
    Oral selective estrogen receptor degraders (SERDs) for the treatment of hormone receptor-positive, HER2-negative breast cancer title: oral selective estrogen receptor degraders (SERDs) for the treatment of hormone receptor-positive, HER2-negative breast cancer. (PubMed, Expert Opin Pharmacother)
    Oral SERDs are reshaping the management of ESR1-mutant disease, with agents such as elacestrant and imlunestrant emerging as standard second-line options. However, primary resistance to SERD monotherapy remains substantial, highlighting the need for combination strategies. Future directions include ctDNA-guided approaches and expansion into earlier treatment settings.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HR positive • HER-2 negative • ESR1 mutation • HR positive + HER-2 negative • HER-2 negative + HR positive + ESR1 mutation
    |
    Orserdu (elacestrant) • Inluriyo (imlunestrant)
    1m
    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, Recruiting, European Institute of Oncology | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    exemestane • Orserdu (elacestrant)
    1m
    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, Recruiting, Istituto Europeo Di Oncologia S.r.l. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    exemestane • Orserdu (elacestrant)
    1m
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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 Risk of Recurrence (ROR) Test
    |
    tamoxifen • Orserdu (elacestrant) • triptorelin