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    BIOMARKER:

    ER mutation

    i
    Entrez ID:
    2099
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Related tests:
    Apply
    Prevalence of Emerging Treatment-induced Mutations in Metastatic ER-positive Breast Cancer. (Pangeia-2) (NCT06417801)
    Phase N/A
    AstraZeneca
    Recruiting
    Last update posted :
    02/13/2025
    Initiation :
    06/17/2024
    Primary completion :
    12/30/2025
    Completion :
    12/30/2025
    ER
    |
    ER mutation • ESR1 mutation
    Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) (NCT04964934)
    Phase 3
    AstraZeneca
    Recruiting
    Last update posted :
    06/04/2024
    Initiation :
    06/30/2021
    Primary completion :
    04/25/2025
    Completion :
    11/26/2027
    HER-2 • ER
    |
    ER positive • HR positive • HER-2 negative • ER mutation • ESR1 mutation • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • letrozole • anastrozole • camizestrant (AZD9833)
    Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. (ADELA) (NCT06382948)
    Phase 3
    MedSIR
    Not yet recruiting
    Last update posted :
    04/26/2024
    Initiation :
    06/01/2024
    Primary completion :
    09/01/2027
    Completion :
    04/01/2028
    HER-2 • ER • CDK4
    |
    HER-2 mutation • ER mutation • ESR1 mutation • CDK4 mutation
    |
    everolimus • Orserdu (elacestrant)
    Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (ELAINE 1) (NCT03781063)
    Phase 2
    Sermonix Pharmaceuticals Inc.
    Active, not recruiting
    Last update posted :
    04/18/2024
    Initiation :
    09/20/2019
    Primary completion :
    12/01/2024
    Completion :
    12/01/2024
    HER-2 • ER
    |
    HER-2 negative • ER mutation • ER Y537S • ER D538G • ESR1 mutation • ER Y537N • ER L536Q • ER Y537C
    |
    fulvestrant • Fablyn (lasofoxifene)
    Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study (NCT04256941)
    Phase 2
    M.D. Anderson Cancer Center
    Completed
    Last update posted :
    04/16/2024
    Initiation :
    05/31/2019
    Primary completion :
    09/22/2023
    Completion :
    09/22/2023
    ER • PGR
    |
    ER positive • HR positive • ER mutation • ER Y537S • ER D538G • ESR1 mutation
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole
    A Phase I Clinical Trial of FWD1802 in Patients With ER+/HER2- BC. (NCT06064812)
    Phase 1
    Forward Pharmaceuticals Co., Ltd.
    Recruiting
    Last update posted :
    10/17/2023
    Initiation :
    09/12/2023
    Primary completion :
    11/01/2025
    Completion :
    02/01/2026
    HER-2 • ER • PGR
    |
    HER-2 negative • ER mutation • ESR1 mutation
    |
    Ibrance (palbociclib)
    Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer (NCT06062498)
    Phase 2
    Northwestern University
    Not yet recruiting
    Last update posted :
    10/02/2023
    Initiation :
    09/30/2023
    Primary completion :
    07/01/2024
    Completion :
    07/01/2025
    HER-2 • ER
    |
    ER positive • HER-2 negative • ER mutation • ESR1 mutation
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • Orserdu (elacestrant)
    PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection (PADA-1) (NCT03079011)
    Phase 3
    UNICANCER
    Active, not recruiting
    Last update posted :
    09/22/2023
    Initiation :
    03/22/2017
    Primary completion :
    04/30/2021
    Completion :
    06/30/2025
    HER-2 • ER
    |
    ER positive • HER-2 negative • ER mutation • ESR1 mutation
    |
    Ibrance (palbociclib) • fulvestrant • letrozole • anastrozole • exemestane
    Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies (NCT04566393)
    Phase N/A
    xCures
    Available
    Last update posted :
    08/21/2023
    BRAF • NRAS • HRAS • MAPK1
    |
    BRAF mutation • ER mutation • HRAS mutation
    |
    ulixertinib (BVD-523)
    CIrCuLAting Dna ESr1 Gene Mutations Analysis (CICLADES) (NCT03318263)
    Phase N/A
    Institut de Cancérologie de Lorraine
    Completed
    Last update posted :
    08/04/2023
    Initiation :
    12/07/2017
    Primary completion :
    12/22/2022
    Completion :
    12/22/2022
    HER-2 • ER • PIK3CA • AKT1
    |
    ER positive • HER-2 negative • PIK3CA mutation • ER mutation • ESR1 mutation • AKT1 mutation • ER positive + HER-2 negative
    Study of TFX06 in Women With Advanced Breast Cancer. (NCT05927779)
    Phase 1/2
    Shenzhen Yangli Pharmaceutical Technology Co., Ltd
    Recruiting
    Last update posted :
    06/30/2023
    Initiation :
    04/17/2023
    Primary completion :
    12/30/2024
    Completion :
    04/30/2025
    HER-2 • CDK4
    |
    ER mutation • ESR1 mutation
    |
    TFX06
    FES Imaging to Optimize Tamoxifen for Metastatic Breast Cancer (NCT04174352)
    Phase 1
    University of Wisconsin, Madison
    Recruiting
    Last update posted :
    06/15/2023
    Initiation :
    10/20/2020
    Primary completion :
    12/01/2024
    Completion :
    12/01/2025
    HER-2 • ER • CDK4
    |
    HER-2 negative • ER mutation • ESR1 mutation • ER expression
    |
    tamoxifen
    PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection (PADA-1) (2016-004360-18)
    Phase 3
    UNICANCER
    Active, not recruiting
    Last update posted :
    08/15/2022
    Initiation :
    03/22/2017
    Primary completion :
    04/30/2021
    Completion :
    06/30/2025
    HER-2 • ER
    |
    ER positive • HER-2 negative • ER mutation
    |
    Ibrance (palbociclib)
    Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib (NCT02913430)
    Phase 1
    Shannon Puhalla
    Active, not recruiting
    Last update posted :
    07/26/2021
    Initiation :
    04/24/2018
    Primary completion :
    10/28/2020
    Completion :
    10/28/2021
    ER
    |
    ER mutation • ESR1 mutation
    |
    Ibrance (palbociclib) • tamoxifen • fulvestrant
    Study of ESR1 Mutations in Metastatic Breast Cancer (FMER) (NCT02473120)
    Phase N/A
    Centre Henri Becquerel
    Completed
    Last update posted :
    07/30/2020
    Initiation :
    06/01/2015
    Primary completion :
    09/01/2019
    Completion :
    10/01/2019
    ER
    |
    ER mutation • ESR1 mutation
    Phase I Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients With Advanced Malignancies (NCT01781429)
    Phase 1/2
    BioMed Valley Discoveries, Inc
    Completed
    Last update posted :
    03/20/2020
    Initiation :
    03/01/2013
    Primary completion :
    02/01/2018
    Completion :
    09/01/2018
    BRAF
    |
    BRAF mutation • NRAS mutation • ER mutation
    |
    ulixertinib (BVD-523)
    The Efficacy of Fulvestrant in ESR1(Estrogen Receptor 1) Mutated Metastatic Breast Cancer (NCT03202862)
    Phase 2
    Fudan University
    Unknown status
    Last update posted :
    06/29/2017
    Initiation :
    07/01/2017
    Primary completion :
    06/01/2019
    Completion :
    08/01/2019
    ER • PGR
    |
    ER mutation • ER Y537S • ER D538G • ESR1 mutation • ER Y537N • ER Y537C
    |
    fulvestrant