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    BIOMARKER:

    ESR1 mutation

    i
    Entrez ID:
    2099
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Related tests:
    Apply
    Evaluation of Lasofoxifene Combined with Abemaciclib Compared with Fulvestrant Combined with Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation (ELAINE 3) (NCT05696626)
    Phase 3
    Sermonix Pharmaceuticals Inc.
    Recruiting
    Last update posted :
    02/24/2025
    Initiation :
    10/31/2023
    Primary completion :
    04/01/2027
    Completion :
    04/01/2028
    ER
    |
    ESR1 mutation
    |
    Verzenio (abemaciclib) • fulvestrant • Fablyn (lasofoxifene)
    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
    Integrated Testing Strategy for Simultaneous Detection of ESR-1 and GBRCA Mutations Via Liquid Biopsy in HR+/HER2- Metastatic Breast Cancer (mBC) Patients, (L2-268) (NCT06762483)
    Phase N/A
    European Institute of Oncology
    Recruiting
    Last update posted :
    01/07/2025
    Initiation :
    12/20/2024
    Primary completion :
    12/31/2026
    Completion :
    12/31/2030
    ER
    |
    ESR1 mutation
    Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors (PEARL) (NCT02028507)
    Phase 3
    Spanish Breast Cancer Research Group
    Completed
    Last update posted :
    09/25/2024
    Initiation :
    03/13/2014
    Primary completion :
    01/14/2019
    Completion :
    01/11/2021
    HER-2 • ER • PGR
    |
    HER-2 negative • ESR1 mutation
    |
    Ibrance (palbociclib) • capecitabine • fulvestrant • exemestane
    A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With The Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer) (ML43171) (NCT05306340)
    Phase 3
    Genentech, Inc.
    Recruiting
    Last update posted :
    06/05/2024
    Initiation :
    08/03/2022
    Primary completion :
    10/03/2024
    Completion :
    03/31/2026
    HER-2 • ER
    |
    ER positive • HER-2 negative • ESR1 mutation
    |
    everolimus • tamoxifen • fulvestrant • exemestane • giredestrant (GDC-9545)
    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)
    OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer (OPERA-01) (NCT06016738)
    Phase 3
    Olema Pharmaceuticals, Inc.
    Recruiting
    Last update posted :
    05/31/2024
    Initiation :
    11/16/2023
    Primary completion :
    06/30/2026
    Completion :
    09/30/2027
    HER-2 • ER
    |
    HER-2 negative • ESR1 mutation
    |
    fulvestrant • letrozole • anastrozole • exemestane • palazestrant (OP-1250)
    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
    Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor (NCT02738866)
    Phase 2
    Sidney Kimmel Comprehensive Cancer Center at Jo...
    Active, not recruiting
    Last update posted :
    02/02/2024
    Initiation :
    10/25/2016
    Primary completion :
    07/01/2024
    Completion :
    12/01/2024
    HER-2 • ER • PGR • PI3K
    |
    ER positive • HER-2 negative • ER positive + PGR positive • ESR1 mutation
    |
    Ibrance (palbociclib) • fulvestrant
    NIS Study Determining Prevalence of HER2-low in Metastatic Breast Cancer Patients (iRetroBC) (NCT06131424)
    Phase N/A
    AstraZeneca
    Not yet recruiting
    Last update posted :
    01/24/2024
    Initiation :
    03/04/2024
    Primary completion :
    09/30/2024
    Completion :
    09/30/2024
    HER-2 • ER • PIK3CA • BRCA1 • PTEN • ATM • AKT1
    |
    BRCA2 mutation • BRCA1 mutation • HER-2 negative • PIK3CA mutation • HER-2 expression • ATM mutation • PALB2 mutation • ESR1 mutation • BRCA1 mutation + BRCA2 mutation
    Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer (H3B-6545-A001-101) (NCT03250676)
    Phase 1/2
    Eisai Inc.
    Completed
    Last update posted :
    12/25/2023
    Initiation :
    08/17/2017
    Primary completion :
    10/26/2023
    Completion :
    10/26/2023
    HER-2 • ER
    |
    ER positive • HER-2 negative • ER Y537S • ER D538G • ESR1 mutation
    |
    H3B-6545
    STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER) (NCT05716516)
    Phase 2
    Dartmouth-Hitchcock Medical Center
    Recruiting
    Last update posted :
    11/15/2023
    Initiation :
    05/04/2023
    Primary completion :
    05/01/2026
    Completion :
    05/01/2027
    ER
    |
    ESR1 mutation
    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
    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
    Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA (MAGNETIC1) (NCT05814224)
    Phase N/A
    Centro di Riferimento Oncologico - Aviano
    Recruiting
    Last update posted :
    04/14/2023
    Initiation :
    05/22/2018
    Primary completion :
    12/31/2023
    Completion :
    12/01/2024
    HER-2 • ER
    |
    ER positive • HER-2 negative • ESR1 mutation
    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
    Plasma Circulating Tumor DNA Analyses in ER+ Metastatic Breast Cancer (NCT03161834)
    Phase N/A
    UNC Lineberger Comprehensive Cancer Center
    Withdrawn
    Last update posted :
    05/21/2021
    Initiation :
    01/13/2017
    Primary completion :
    07/09/2020
    Completion :
    07/09/2020
    HER-2 • ER
    |
    ESR1 mutation
    ESR1 Mutations in Asian ER+ Metastatic Breast Cancer on Hormonal Therapy-based Treatments (NCT04212702)
    Phase N/A
    National Taiwan University Hospital
    Active, not recruiting
    Last update posted :
    01/12/2021
    Initiation :
    05/22/2017
    Primary completion :
    02/01/2020
    Completion :
    12/31/2021
    HER-2 • ER • PGR
    |
    HER-2 positive • ER positive • HER-2 negative • ESR1 mutation • ER positive + HER-2 negative
    |
    everolimus
    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
    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