^
    1d
    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)
    9d
    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
    |
    ER (Estrogen receptor)
    |
    ER positive • ESR1 mutation
    |
    Orserdu (elacestrant)
    13d
    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)
    19d
    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)
    26d
    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)
    28d
    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)
    1m
    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)
    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, 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
    2ms
    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)
    2ms
    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)