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    Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer (ELEVATE) (NCT05563220)
    Phase 1/2
    Stemline Therapeutics, Inc.
    Recruiting
    Last update posted :
    02/18/2025
    Initiation :
    01/24/2023
    Primary completion :
    12/27/2026
    Completion :
    12/28/2028
    HER-2 • ER • PIK3CA • CDK4
    |
    PIK3CA mutation
    |
    Ibrance (palbociclib) • everolimus • Piqray (alpelisib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • Truqap (capivasertib) • Orserdu (elacestrant)
    An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) (NCT05952557)
    Phase 3
    AstraZeneca
    Recruiting
    Last update posted :
    02/18/2025
    Initiation :
    10/05/2023
    Primary completion :
    03/04/2030
    Completion :
    05/06/2037
    HER-2 • ER
    |
    HER-2 negative
    |
    tamoxifen • Verzenio (abemaciclib) • letrozole • anastrozole • exemestane • camizestrant (AZD9833)
    A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer (SERENA-2) (NCT04214288)
    Phase 2
    AstraZeneca
    Active, not recruiting
    Last update posted :
    02/14/2025
    Initiation :
    04/22/2020
    Primary completion :
    08/30/2022
    Completion :
    03/28/2025
    HER-2 • ER
    |
    HER-2 positive • ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    fulvestrant • camizestrant (AZD9833)
    A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy (CAMBRIA-1) (NCT05774951)
    Phase 3
    AstraZeneca
    Recruiting
    Last update posted :
    02/11/2025
    Initiation :
    03/31/2023
    Primary completion :
    04/20/2027
    Completion :
    05/29/2036
    HER-2 • ER
    |
    HER-2 negative
    |
    tamoxifen • letrozole • anastrozole • exemestane • camizestrant (AZD9833)
    Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to ER+/HER-2- Breast Cancer (ELECTRA) (NCT05386108)
    Phase 1/2
    Stemline Therapeutics, Inc.
    Recruiting
    Last update posted :
    02/11/2025
    Initiation :
    08/31/2022
    Primary completion :
    12/01/2025
    Completion :
    12/01/2025
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Verzenio (abemaciclib) • Orserdu (elacestrant)
    A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) (NCT04961996)
    Phase 3
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/10/2025
    Initiation :
    08/27/2021
    Primary completion :
    03/31/2026
    Completion :
    11/21/2033
    HER-2 • ER
    |
    ER positive • HER-2 negative
    |
    tamoxifen • Verzenio (abemaciclib) • giredestrant (GDC-9545)
    ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study (ELCIN) (NCT05596409)
    Phase 2
    Stemline Therapeutics, Inc.
    Recruiting
    Last update posted :
    02/07/2025
    Initiation :
    05/19/2023
    Primary completion :
    02/01/2025
    Completion :
    08/01/2025
    HER-2 • ER
    |
    Orserdu (elacestrant)
    A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) (NCT06065748)
    Phase 3
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/05/2025
    Initiation :
    12/11/2023
    Primary completion :
    07/30/2026
    Completion :
    12/30/2028
    HER-2 • ER • CDK4
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • giredestrant (GDC-9545)
    A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer) (NCT05296798)
    Phase 3
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/04/2025
    Initiation :
    07/04/2022
    Primary completion :
    03/31/2027
    Completion :
    12/31/2030
    HER-2 • ER
    |
    ER positive • EGFR positive
    |
    paclitaxel • docetaxel • tamoxifen • Perjeta (pertuzumab) • giredestrant (GDC-9545) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10% (EMPRESS) (NCT05659563)
    Phase 2
    MedSIR
    Completed
    Last update posted :
    02/04/2025
    Initiation :
    07/20/2023
    Primary completion :
    01/30/2025
    Completion :
    01/30/2025
    HER-2 • ER
    |
    HER-2 negative
    |
    tamoxifen • giredestrant (GDC-9545) • Soltamox (tamoxifen citrate)
    A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer (NCT05509790)
    Phase 1
    Eli Lilly and Company
    Active, not recruiting
    Last update posted :
    01/24/2025
    Initiation :
    10/09/2022
    Primary completion :
    02/18/2024
    Completion :
    12/01/2025
    HER-2 • ER
    |
    HER-2 negative
    |
    Inluriyo (imlunestrant)
    A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer (EMBER-3) (NCT04975308)
    Phase 3
    Eli Lilly and Company
    Active, not recruiting
    Last update posted :
    01/24/2025
    Initiation :
    10/04/2021
    Primary completion :
    06/24/2024
    Completion :
    08/01/2027
    HER-2 • ER
    |
    HER-2 negative
    |
    Verzenio (abemaciclib) • fulvestrant • exemestane • Inluriyo (imlunestrant)
    A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (EMBER-4) (NCT05514054)
    Phase 3
    Eli Lilly and Company
    Recruiting
    Last update posted :
    01/22/2025
    Initiation :
    10/04/2022
    Primary completion :
    10/01/2027
    Completion :
    03/01/2032
    HER-2 • ER
    |
    HER-2 negative
    |
    tamoxifen • letrozole • anastrozole • exemestane • Inluriyo (imlunestrant)
    A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer (EMBER) (NCT04188548)
    Phase 1
    Eli Lilly and Company
    Active, not recruiting
    Last update posted :
    01/22/2025
    Initiation :
    12/10/2019
    Primary completion :
    06/29/2020
    Completion :
    12/01/2027
    ER
    |
    HER-2 negative • EGFR positive
    |
    Herceptin (trastuzumab) • everolimus • Perjeta (pertuzumab) • Piqray (alpelisib) • Verzenio (abemaciclib) • exemestane • Inluriyo (imlunestrant)
    Phase 1b Combo w/ Ribociclib, Alpelisib, or Everolimus (OP-1250-003) (NCT05508906)
    Phase 1
    Olema Pharmaceuticals, Inc.
    Recruiting
    Last update posted :
    10/03/2024
    Initiation :
    08/31/2022
    Primary completion :
    05/20/2026
    Completion :
    06/30/2026
    HER-2
    |
    HER-2 negative
    |
    everolimus • Piqray (alpelisib) • Kisqali (ribociclib) • palazestrant (OP-1250)
    A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer) (acelERA BC) (NCT04576455)
    Phase 2
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    06/06/2024
    Initiation :
    11/27/2020
    Primary completion :
    02/18/2022
    Completion :
    06/27/2025
    HER-2 • ER
    |
    ER positive • HER-2 negative
    |
    fulvestrant • giredestrant (GDC-9545)
    A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer (GO39932) (NCT03332797)
    Phase 1
    Genentech, Inc.
    Active, not recruiting
    Last update posted :
    06/06/2024
    Initiation :
    11/27/2017
    Primary completion :
    06/30/2025
    Completion :
    06/30/2025
    HER-2 • ER
    |
    HER-2 positive • ER positive • HER-2 negative • ER positive + HER-2 negative
    |
    Ibrance (palbociclib) • triptorelin • goserelin acetate • giredestrant (GDC-9545)
    A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer) (NCT04546009)
    Phase 3
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    06/05/2024
    Initiation :
    10/09/2020
    Primary completion :
    03/31/2025
    Completion :
    03/18/2027
    HER-2 • ER
    |
    ER positive • HER-2 negative • ER positive + HER-2 negative
    |
    Ibrance (palbociclib) • letrozole • giredestrant (GDC-9545)
    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 • dexamethasone • exemestane • giredestrant (GDC-9545)
    A Phase 1 Study of AZD9833 in Japanese Women With ER Positive, HER2 Negative Advanced Breast Cancer (NCT04541433)
    Phase 1
    AstraZeneca
    Active, not recruiting
    Last update posted :
    06/05/2024
    Initiation :
    09/29/2020
    Primary completion :
    07/29/2022
    Completion :
    12/31/2025
    HER-2 • ER
    |
    HER-2 negative
    |
    camizestrant (AZD9833)
    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)
    A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population (MiRaDoR) (NCT05708235)
    Phase 2
    MedSIR
    Recruiting
    Last update posted :
    05/29/2024
    Initiation :
    04/01/2024
    Primary completion :
    12/30/2028
    Completion :
    12/30/2028
    HER-2 • PIK3CA
    |
    HR positive • HER-2 negative • PIK3CA mutation
    |
    Verzenio (abemaciclib) • Itovebi (inavolisib) • giredestrant (GDC-9545)
    FUlvestrant in Gynecological Cancers That Are Potentially Hormone Sensitive: the FUCHSia Study (NCT03926936)
    Phase 2
    Frederic Amant
    Completed
    Last update posted :
    05/27/2024
    Initiation :
    03/13/2019
    Primary completion :
    04/01/2022
    Completion :
    12/27/2022
    ER
    |
    ER positive
    |
    fulvestrant
    Endocrine Response in Women With Invasive Lobular Breast Cancer (NCT02206984)
    Phase 2
    Priscilla McAuliffe
    Active, not recruiting
    Last update posted :
    05/14/2024
    Initiation :
    09/30/2015
    Primary completion :
    07/31/2024
    Completion :
    07/31/2024
    HER-2
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    tamoxifen • fulvestrant • anastrozole
    Molecular Imaging of Fulvestrant Effects on Availability of ER Binding Sites (NCT01377324)
    Phase 2
    University Medical Center Groningen
    Completed
    Last update posted :
    05/06/2024
    Initiation :
    05/01/2011
    Primary completion :
    08/01/2013
    Completion :
    08/01/2013
    ER
    |
    ER positive
    |
    fulvestrant
    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)
    Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer (AMEERA-3) (NCT04059484)
    Phase 2
    Sanofi
    Active, not recruiting
    Last update posted :
    04/24/2024
    Initiation :
    10/22/2019
    Primary completion :
    02/15/2022
    Completion :
    09/30/2024
    HER-2 • ER
    |
    ER positive • HER-2 negative
    |
    tamoxifen • fulvestrant • letrozole • anastrozole • exemestane • amcenestrant (SAR439859)
    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 Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer (PREcoopERA) (NCT05896566)
    Phase 2
    ETOP IBCSG Partners Foundation
    Recruiting
    Last update posted :
    04/05/2024
    Initiation :
    01/23/2024
    Primary completion :
    06/01/2026
    Completion :
    06/01/2026
    HER-2 • ER
    |
    ER positive • HER-2 negative
    |
    anastrozole • triptorelin • giredestrant (GDC-9545)
    Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer (EMERALD) (NCT03778931)
    Phase 3
    Stemline Therapeutics, Inc.
    Active, not recruiting
    Last update posted :
    03/29/2024
    Initiation :
    05/10/2019
    Primary completion :
    08/24/2021
    Completion :
    08/01/2024
    HER-2 • ER
    |
    fulvestrant • letrozole • anastrozole • exemestane • Orserdu (elacestrant)
    DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment (NCT06075953)
    Phase 2
    QuantumLeap Healthcare Collaborative
    Recruiting
    Last update posted :
    03/27/2024
    Initiation :
    02/14/2024
    Primary completion :
    11/01/2028
    Completion :
    11/01/2033
    HER-2
    |
    HR positive
    |
    tamoxifen • letrozole • anastrozole • exemestane • Orserdu (elacestrant)
    A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease (SERENA-4) (NCT04711252)
    Phase 3
    AstraZeneca
    Active, not recruiting
    Last update posted :
    03/26/2024
    Initiation :
    01/28/2021
    Primary completion :
    08/24/2026
    Completion :
    02/01/2029
    HER-2 • ER
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • anastrozole • camizestrant (AZD9833)
    Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer. (SERENA-1) (NCT03616587)
    Phase 1
    AstraZeneca
    Active, not recruiting
    Last update posted :
    03/05/2024
    Initiation :
    10/11/2018
    Primary completion :
    07/10/2024
    Completion :
    09/30/2024
    HER-2 • ER
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • Kisqali (ribociclib) • Truqap (capivasertib) • anastrozole • camizestrant (AZD9833)
    A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer (NCT05187832)
    Phase 1
    Kind Pharmaceuticals LLC
    Recruiting
    Last update posted :
    02/29/2024
    Initiation :
    10/05/2022
    Primary completion :
    05/01/2026
    Completion :
    05/01/2026
    HER-2 • ER
    |
    HER-2 negative
    |
    AND019
    500mg Fulvestrant in HR+ MBC (NCT03708432)
    Phase N/A
    Fudan University
    Completed
    Last update posted :
    02/26/2024
    Initiation :
    07/15/2017
    Primary completion :
    06/15/2018
    Completion :
    08/15/2018
    HER-2 • PGR
    |
    HER-2 negative
    |
    fulvestrant
    Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer (SOLTI-2104) (NCT05982093)
    Phase 2
    SOLTI Breast Cancer Research Group
    Recruiting
    Last update posted :
    02/13/2024
    Initiation :
    10/03/2023
    Primary completion :
    10/01/2024
    Completion :
    01/01/2025
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative • HER-2 expression
    |
    Orserdu (elacestrant) • triptorelin
    Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer (AMEERA-1) (NCT03284957)
    Phase 1/2
    Sanofi
    Active, not recruiting
    Last update posted :
    02/12/2024
    Initiation :
    09/20/2017
    Primary completion :
    12/29/2027
    Completion :
    12/29/2027
    HER-2 • ER
    |
    Ibrance (palbociclib) • everolimus • Piqray (alpelisib) • Verzenio (abemaciclib) • amcenestrant (SAR439859) • midazolam hydrochloride
    Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy. (CONFIRM) (NCT00099437)
    Phase 3
    AstraZeneca
    Active, not recruiting
    Last update posted :
    02/12/2024
    Initiation :
    02/13/2005
    Primary completion :
    02/27/2009
    Completion :
    03/29/2024
    ER
    |
    fulvestrant
    Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA) (NCT05512364)
    Phase 3
    European Organisation for Research and Treatmen...
    Recruiting
    Last update posted :
    01/24/2024
    Initiation :
    12/15/2023
    Primary completion :
    07/01/2028
    Completion :
    05/01/2030
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative • ER positive + HER-2 negative
    |
    tamoxifen • letrozole • anastrozole • exemestane • Orserdu (elacestrant)
    Evaluating the Addition of Elacestrant (Oral SERD) to Niraparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer (ELEMENT) (NCT06201234)
    Phase 2
    German Breast Group
    Not yet recruiting
    Last update posted :
    01/11/2024
    Initiation :
    03/31/2024
    Primary completion :
    03/31/2028
    Completion :
    03/31/2028
    HER-2 • BRCA1
    |
    HER-2 negative • PALB2 mutation • PTEN mutation + HR positive
    |
    Zejula (niraparib) • Orserdu (elacestrant)