^
    8d
    Characterization of In Vitro Metabolic Profiles of Elacestrant in Rat and Human Liver Microsomes Using HPLC-MS/MS and HPLC-Q-Orbitrap-HRMS. (PubMed, Biomed Chromatogr)
    Key metabolic pathways involved O-demethylation, N-deethylation, N-dealkylation, and oxidative deamination, primarily mediated by cytochrome P450 3A4. This study establishes the first HPLC-MS/MS and HPLC-Q-Orbitrap-HRMS-based analytical strategy for in vitro metabolic profiling of elacestrant, supporting its future application in clinical pharmacokinetic and metabolism investigations.
    Preclinical • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Orserdu (elacestrant)
    12d
    PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) (clinicaltrials.gov)
    P2, N=297, Recruiting, Kristina A. Fanucci | Trial completion date: Oct 2029 --> Oct 2030 | Trial primary completion date: Dec 2028 --> Dec 2029
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CD4 (CD4 Molecule)
    |
    ER positive • HER-2 negative • ESR1 mutation • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
    |
    capecitabine • Orserdu (elacestrant)
    13d
    PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) (clinicaltrials.gov)
    P2, N=297, Recruiting, Kristina A. Fanucci | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CD4 (CD4 Molecule)
    |
    ER positive • HER-2 negative • ESR1 mutation • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
    |
    capecitabine • Orserdu (elacestrant)
    20d
    A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=240, Recruiting, Stemline Therapeutics, Inc. | Trial primary completion date: Oct 2025 --> Jun 2026
    Trial primary completion date • 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
    21d
    Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer (clinicaltrials.gov)
    P2, N=24, Active, not recruiting, University of Miami | Recruiting --> Active, not recruiting | N=500 --> 24
    Enrollment closed • Enrollment change • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Lynparza (olaparib) • Ibrance (palbociclib) • everolimus • tamoxifen • Talzenna (talazoparib) • capecitabine • Piqray (alpelisib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • Halaven (eribulin mesylate) • Truqap (capivasertib) • letrozole • anastrozole • exemestane • Orserdu (elacestrant) • Navelbine oral (vinorelbine tartrate oral)
    1m
    Elacestrant in metastatic breast cancer: current advancements and future perspectives. (PubMed, Expert Rev Anticancer Ther)
    With the growing integration of liquid biopsy technologies and molecular monitoring into clinical practice, dynamic treatment adaptation guided by real time molecular profiling is expected to refine therapy selection. Elacestrant is a benchmark in the shift toward individualized endocrine therapy in metastatic breast cancer, bridging molecular precision with clinical practicality.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    HR positive • HER-2 negative • ESR1 mutation • HR positive + HER-2 negative • HER-2 negative + HR positive + ESR1 mutation
    |
    Orserdu (elacestrant)
    2ms
    ADELA: Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. (clinicaltrials.gov)
    P3, N=240, Active, not recruiting, MedSIR | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 mutation
    |
    everolimus • dexamethasone • Orserdu (elacestrant)
    2ms
    POP-ELA: A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer (clinicaltrials.gov)
    P2, N=140, Recruiting, Gustave Roussy, Cancer Campus, Grand Paris | Not yet recruiting --> Recruiting
    Enrollment open
    |
    ER positive
    |
    Orserdu (elacestrant) • leuprolide acetate for depot suspension
    2ms
    Safety evaluation of selective estrogen receptor degraders (SERDs) using real-world evidence from the FDA Adverse Event Reporting System (FAERS). (PubMed, Sci Rep)
    The analysis commenced with elacestrant (2022) and fulvestrant (2004), concluding in the fourth quarter of 2024. For fulvestrant, increased vigilance is necessary regarding cancer metastasis and adverse events impacting the hematological and lymphatic systems. It is recommended that targeted monitoring be enhanced in clinical practice in accordance with the distinct characteristics of each drug.
    Journal • Adverse events • HEOR • Real-world evidence
    |
    ER (Estrogen receptor)
    |
    fulvestrant • 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
    New P3 trial
    |
    MammaPrint® • Oncotype DX Breast Recurrence Score®Test
    |
    Orserdu (elacestrant)
    3ms
    Real-World Outcomes of Elacestrant in ER+, HER2-, ESR1-mutant Metastatic Breast Cancer. (PubMed, Clin Cancer Res)
    Elacestrant demonstrated durable benefit in real-world clinical practice, particularly in earlier lines and in patients with prolonged prior ET exposure. Despite coexisting ESR1 and PI3K-pathway mutations, TTNT remained clinically meaningful, reinforcing the role of elacestrant in personalized ET sequencing strategies prior to chemotherapy, antibody-drug conjugates, or targeted combinations.
    Journal • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    ER positive • HER-2 negative • ESR1 mutation • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
    |
    fulvestrant • Orserdu (elacestrant)
    3ms
    Discovery of a novel small molecule degrader of wild type and mutant estrogen receptors using DNA encoded libraries. (PubMed, NPJ Breast Cancer)
    We demonstrated that CDD-1274 induced proteasomal degradation of ERα variants in breast cancer cell lines and caused Y537S ERα degradation more effectively than elacestrant in a palbociclib-resistant cell line. These findings establish that CDD-1274 potently blocks ligand-dependent and ligand-independent ER signaling in endocrine-resistant breast cancer cells and could be further optimized for developing a new class of ERα degraders for endocrine therapy-resistant breast cancer.
    Journal
    |
    ER (Estrogen receptor)
    |
    ER positive • ER negative
    |
    Ibrance (palbociclib) • Orserdu (elacestrant)