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    Selective estrogen receptor modulator

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    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)
    Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer (NCT05941520)
    Phase 2
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/21/2025
    Initiation :
    08/23/2024
    Primary completion :
    08/23/2027
    Completion :
    09/01/2028
    TP53 • PTEN • ATM • NF1 • MSH6 • CDH1 • CHEK2 • BRIP1 • RAD51C • RAD51D • BARD1 • NBN • AGR2
    |
    TP53 mutation • ATM mutation • CHEK2 mutation • BRIP1 mutation • RAD51C mutation • RAD51D mutation • BARD1 mutation
    |
    tamoxifen • acolbifene
    Endoxifen in Adults With Hormone Receptor Positive Solid Tumors (NCT01273168)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/21/2025
    Initiation :
    03/01/2011
    Primary completion :
    06/01/2020
    Completion :
    06/01/2026
    HER-2
    |
    tamoxifen • Zonalta (Z-endoxifen hydrochloride)
    Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (ELAINEII) (NCT04432454)
    Phase 2
    Sermonix Pharmaceuticals Inc.
    Completed
    Last update posted :
    02/13/2025
    Initiation :
    09/29/2020
    Primary completion :
    01/28/2025
    Completion :
    01/28/2025
    HER-2 • ER
    |
    HER-2 negative
    |
    Verzenio (abemaciclib) • Fablyn (lasofoxifene)
    Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer (NCT02311933)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/03/2025
    Initiation :
    05/28/2015
    Primary completion :
    11/06/2020
    Completion :
    02/04/2025
    ER • NCOA3
    |
    ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    Zonalta (Z-endoxifen hydrochloride) • Soltamox (tamoxifen citrate)
    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)
    Z-Endoxifen Hydrochloride in Treating Patients With Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer (NCT01327781)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/26/2024
    Initiation :
    03/25/2011
    Primary completion :
    03/05/2017
    Completion :
    10/30/2024
    EGFR • HER-2 • ER • PGR • AKT1 • mTOR • IGF1R • NCOA3 • PI3K
    |
    ER positive • HER-2 expression • EGFR expression
    |
    Zonalta (Z-endoxifen hydrochloride)
    Combined Estrogen Blockade of the Breast With Exemestane and Raloxifene in Postmenopausal Women With a History of Breast Cancer Who Have No Clinical Evidence of Disease (NCT00200174)
    Phase N/A
    Memorial Sloan Kettering Cancer Center
    Completed
    Last update posted :
    07/04/2023
    Initiation :
    07/01/1999
    Primary completion :
    07/01/2003
    Completion :
    08/01/2008
    PGR
    |
    exemestane • raloxifene hydrochloride
    The PROMISE Study: Duavee in Women With DCIS (NCT02694809)
    Phase 2
    Northwestern University
    Recruiting
    Last update posted :
    02/07/2023
    Initiation :
    01/01/2017
    Primary completion :
    08/01/2023
    Completion :
    07/01/2024
    HER-2 • PGR • CD36 • PTGS2
    |
    HER-2 expression • PGR expression
    A Study of Palbociclib in Combination With Bazedoxifene in Hormone Receptor Positive Breast Cancer (NCT02448771)
    Phase 1/2
    Dana-Farber Cancer Institute
    Completed
    Last update posted :
    10/24/2022
    Initiation :
    07/09/2015
    Primary completion :
    08/12/2019
    Completion :
    03/03/2021
    HER-2 • ER • PGR
    |
    HER-2 negative • PGR positive
    |
    Ibrance (palbociclib)
    Testing an Active Form of Tamoxifen (4-hydroxytamoxifen) Delivered Through the Breast Skin to Control Ductal Carcinoma in Situ (DCIS) of the Breast (NCT02993159)
    Phase 2b
    Northwestern University
    Recruiting
    Last update posted :
    12/21/2020
    Initiation :
    05/31/2017
    Primary completion :
    07/15/2022
    Completion :
    07/15/2023
    ER • IGF1 • CD68
    |
    ER positive
    |
    afimoxifene • Soltamox (tamoxifen citrate)
    Acolbifene in Preventing Cancer in Premenopausal Women at High Risk of Breast Cancer (NCT00853996)
    Phase 2
    University of Kansas Medical Center
    Completed
    Last update posted :
    01/17/2018
    Initiation :
    02/01/2009
    Primary completion :
    12/01/2010
    Completion :
    12/01/2010
    BRCA1 • BRCA2
    |
    BRCA2 mutation • BRCA1 mutation
    |
    acolbifene
    LY353381 in Preventing Breast Cancer in Women With Hyperplasia (NCT00005879)
    Phase 2
    University of Kansas Medical Center
    Completed
    Last update posted :
    05/30/2017
    Initiation :
    08/01/2000
    Primary completion :
    07/01/2008
    Completion :
    07/01/2008
    BRCA1 • BRCA2
    |
    BRCA2 mutation • BRCA1 mutation
    |
    arzoxifene (LY353381)
    Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer (NCT00005886)
    Phase 1
    University of Kansas Medical Center
    Completed
    Last update posted :
    01/13/2017
    Initiation :
    07/01/2000
    Primary completion :
    08/01/2002
    Completion :
    08/01/2002
    PGR
    |
    ER positive + PGR positive • PGR positive
    |
    tamoxifen • Soltamox (tamoxifen citrate) • arzoxifene (LY353381)
    Exemestane and Raloxifene in Treating Postmenopausal Women With a History of Ductal Carcinoma in Situ, Stage I, Stage II, or Stage III Breast Cancer (NCT00004247)
    Phase 2
    Memorial Sloan-Kettering Cancer Center
    Completed
    Last update posted :
    12/23/2015
    Initiation :
    04/01/1999
    Primary completion :
    08/01/2008
    ER
    |
    ER positive • ER negative
    |
    exemestane • raloxifene hydrochloride
    Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer (NCT00020735)
    Phase 2
    Joel Nelson, MD
    Completed
    Last update posted :
    12/02/2015
    Initiation :
    04/01/2001
    Primary completion :
    01/01/2005
    Completion :
    06/01/2009
    BCL2
    |
    toremifene