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    GENE:

    ER (Estrogen receptor)

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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)
    Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET) (NCT05063786)
    Phase 3
    Spanish Breast Cancer Research Group
    Active, not recruiting
    Last update posted :
    02/24/2025
    Initiation :
    09/14/2021
    Primary completion :
    06/01/2025
    Completion :
    06/01/2025
    HER-2 • ER • PIK3CA • PGR
    |
    ER positive • PIK3CA mutation
    |
    Herceptin (trastuzumab) • capecitabine • Piqray (alpelisib) • fulvestrant • Halaven (eribulin mesylate) • vinorelbine tartrate • Navelbine oral (vinorelbine tartrate oral)
    (Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer (EVANGELINE) (NCT05607004)
    Phase 2
    Atossa Therapeutics, Inc.
    Recruiting
    Last update posted :
    02/24/2025
    Initiation :
    02/14/2023
    Primary completion :
    02/01/2026
    Completion :
    09/01/2026
    HER-2 • ER
    |
    HER-2 negative
    |
    exemestane • goserelin acetate
    Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer (S2206) (NCT06058377)
    Phase 3
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/24/2025
    Initiation :
    11/27/2023
    Primary completion :
    05/31/2026
    Completion :
    05/31/2026
    HER-2 • ER • PGR
    |
    HER-2 positive • ER positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Imfinzi (durvalumab) • paclitaxel • doxorubicin hydrochloride • cyclophosphamide • daunorubicin
    Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy (NCT02945579)
    Phase N/A
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    02/24/2025
    Initiation :
    01/20/2017
    Primary completion :
    01/31/2026
    Completion :
    01/31/2026
    ER • PGR
    |
    HER-2 positive • HER-2 negative • PGR positive
    Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced/Metastatic or Unresectable Solid Tumors With RAS Alterations and Triple Negative Breast Cancer (NCI-2021-11793) (NCT05111561)
    Phase 1
    National Cancer Institute (NCI)
    Suspended
    Last update posted :
    02/21/2025
    Initiation :
    08/02/2022
    Primary completion :
    03/14/2025
    Completion :
    03/14/2025
    HER-2 • KRAS • BRAF • ER • PGR • NRAS • HRAS • NF1
    |
    BRAF mutation • HER-2 amplification • HRAS mutation • BRAF fusion
    |
    Mektovi (binimetinib) • ZEN-3694
    A Study of Samuraciclib and Elacestrant in Participants with Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer (SUMIT-ELA) (NCT05963997)
    Phase 1/2
    Carrick Therapeutics Limited
    Active, not recruiting
    Last update posted :
    02/21/2025
    Initiation :
    10/09/2023
    Primary completion :
    12/23/2025
    Completion :
    12/23/2025
    HER-2 • ER • TP53 • CDK4
    |
    TP53 mutation • ER positive • HER-2 negative • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
    |
    Orserdu (elacestrant) • samuraciclib (CT7001)
    Hypofractionated Regional Nodal Irradiation Clinical Trial for Women With Breast Cancer (HeNRIetta) (NCT02515110)
    Phase N/A
    Virginia Commonwealth University
    Active, not recruiting
    Last update posted :
    02/21/2025
    Initiation :
    08/04/2015
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    HER-2 • ER • PGR
    Testing the Addition of an Anti-cancer Drug, Berzosertib, to the Usual Treatment (Radiation Therapy) for Chemotherapy-Resistant Triple-Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast Cancer (NCT04052555)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/21/2025
    Initiation :
    09/24/2020
    Primary completion :
    11/20/2025
    Completion :
    11/20/2025
    HER-2 • ER • PGR
    |
    HER-2 negative
    |
    berzosertib (M6620)
    Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer (NCT04345913)
    Phase 1/2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/21/2025
    Initiation :
    03/01/2021
    Primary completion :
    06/30/2025
    Completion :
    06/30/2025
    ER • PIK3CA • PGR • PTEN
    |
    HER-2 amplification • HER-2 negative • PIK3CA mutation
    |
    Halaven (eribulin mesylate) • Aliqopa (copanlisib)
    A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies (REMERGE) (NCT06274515)
    Phase 4
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/21/2025
    Initiation :
    04/02/2024
    Primary completion :
    09/30/2026
    Completion :
    09/30/2026
    HER-2 • PD-L1 • ER • CDK4
    QUILT-3.057: NANT Neoadjuvant Triple- Negative Breast Cancer (TNBC) Vaccine (NCT03554109)
    Phase 2
    ImmunityBio, Inc.
    Withdrawn
    Last update posted :
    02/21/2025
    Initiation :
    09/01/2018
    Primary completion :
    06/01/2020
    Completion :
    02/09/2022
    HER-2 • ER • PGR
    |
    HER-2 overexpression • HER-2 amplification
    |
    5-fluorouracil • Bavencio (avelumab) • albumin-bound paclitaxel • cyclophosphamide • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011 • ETBX-051 • ETBX-061 • GI-4000 • GI-6207 • GI-6301 • NK92-CD16-158V • aldoxorubicin (INNO-206)
    A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants (SUMIT-BC) (NCT05963984)
    Phase 2
    Carrick Therapeutics Limited
    Active, not recruiting
    Last update posted :
    02/21/2025
    Initiation :
    12/14/2023
    Primary completion :
    06/30/2025
    Completion :
    12/31/2025
    HER-2 • ER • TP53 • CDK4
    |
    TP53 mutation • ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    fulvestrant • samuraciclib (CT7001)
    Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer (Dauntless-1) (NCT04115306)
    Phase 1/2
    Phoenix Molecular Designs
    Recruiting
    Last update posted :
    02/20/2025
    Initiation :
    11/14/2019
    Primary completion :
    12/01/2025
    Completion :
    03/01/2026
    HER-2 • ER
    |
    HER-2 negative
    |
    fulvestrant • PMD-026
    Tracking Triple-negative Breast Cancer Evolution Through Therapy (TRACERX-TNBC) (NCT03077776)
    Phase N/A
    UNICANCER
    Active, not recruiting
    Last update posted :
    02/20/2025
    Initiation :
    04/14/2017
    Primary completion :
    06/01/2024
    Completion :
    05/01/2026
    HER-2 • ER • PGR
    |
    HER-2 negative
    Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer (ECOG-ACRIN 5103) (NCT00433511)
    Phase 3
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/20/2025
    Initiation :
    11/02/2007
    Primary completion :
    01/07/2014
    Completion :
    02/22/2025
    HER-2 • ER
    |
    Avastin (bevacizumab) • paclitaxel • doxorubicin hydrochloride • cyclophosphamide • Aybintio (bevacizumab biosimilar) • Mvasi (bevacizumab-awwb) • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn) • Zirabev (bevacizumab-bvzr) • Airuituo (bevacizumab biosimilar) • Beianting (bevacizumab biosimilar) • Boyounuo (bevacizumab biosimilar) • GB222 (bevacizumab biosimilar) • Hanbeitai (bevacizumab biosimilar) • Vasforda (bevacizumab biosimilar) • cyclophosphamide intravenous
    Study of Palliative Radiation Combined with Pembrolizumab in Unresectable Metastatic Stage IV Breast Cancer (NCT04990921)
    Phase 2
    University of Louisville
    Recruiting
    Last update posted :
    02/20/2025
    Initiation :
    09/02/2021
    Primary completion :
    07/01/2031
    Completion :
    07/01/2031
    HER-2 • ER
    |
    HER-2 overexpression
    |
    Keytruda (pembrolizumab)
    Veliparib, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Non-Hodgkin Lymphoma (NCT00740805)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/20/2025
    Initiation :
    08/18/2008
    Primary completion :
    09/03/2021
    Completion :
    10/22/2025
    HER-2 • ER • PGR • BRCA1 • BRCA
    |
    HER-2 negative • BRCA mutation
    |
    doxorubicin hydrochloride • cyclophosphamide • veliparib (ABT-888) • cyclophosphamide intravenous
    Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients of Different Ages With Metastatic Breast Cancer (NCT00609791)
    Phase 2
    City of Hope Medical Center
    Active, not recruiting
    Last update posted :
    02/19/2025
    Initiation :
    02/11/2008
    Primary completion :
    10/25/2011
    Completion :
    05/15/2025
    HER-2 • ER
    |
    albumin-bound paclitaxel
    Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, Node Positive, HR+/HER2- Breast Cancer (NCT05996107)
    Phase 1
    University of Michigan Rogel Cancer Center
    Recruiting
    Last update posted :
    02/19/2025
    Initiation :
    02/27/2024
    Primary completion :
    06/01/2026
    Completion :
    06/01/2030
    HER-2 • ER • PGR
    |
    HER-2 negative
    |
    Kisqali (ribociclib)
    A Study of ASP1002 in Adults for Treatment of Solid Tumors (NCT05719558)
    Phase 1
    Astellas Pharma Global Development, Inc.
    Recruiting
    Last update posted :
    02/19/2025
    Initiation :
    03/13/2023
    Primary completion :
    04/30/2028
    Completion :
    05/31/2028
    HER-2 • ER • PGR
    |
    HER-2 negative
    |
    ASP1002
    Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer (NCT01463072)
    Phase 2
    City of Hope Medical Center
    Active, not recruiting
    Last update posted :
    02/19/2025
    Initiation :
    06/19/2012
    Primary completion :
    05/17/2017
    Completion :
    06/17/2025
    HER-2 • ER
    |
    albumin-bound paclitaxel
    A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (NCT05852691)
    Phase 2
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    02/19/2025
    Initiation :
    07/18/2023
    Primary completion :
    12/24/2026
    Completion :
    12/24/2026
    HER-2 • PD-L1 • ER • CD4
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • albumin-bound paclitaxel • tobemstomig (RG6139)
    A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors (NCT05836324)
    Phase 1
    Incyte Corporation
    Recruiting
    Last update posted :
    02/19/2025
    Initiation :
    07/24/2023
    Primary completion :
    12/24/2026
    Completion :
    12/24/2026
    HER-2 • BRAF • ER • PGR • ROS1
    |
    HER-2 negative • ER negative
    |
    INCA33890
    Ph II Study of Pembrolizumab & Eribulin in Patients With HR+/HER2- MBC Previously Treated With Anthracyclines & Taxanes (KELLY) (NCT03222856)
    Phase 2
    MedSIR
    Completed
    Last update posted :
    02/19/2025
    Initiation :
    12/14/2017
    Primary completion :
    10/31/2018
    Completion :
    12/23/2020
    HER-2 • PD-L1 • ER • PGR • TMB
    |
    PD-L1 expression • HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Keytruda (pembrolizumab) • Halaven (eribulin mesylate)
    Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-postitive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. (EPIK-B5) (NCT05038735)
    Phase 3
    Novartis Pharmaceuticals
    Recruiting
    Last update posted :
    02/18/2025
    Initiation :
    12/17/2021
    Primary completion :
    12/30/2025
    Completion :
    12/29/2027
    HER-2 • ER • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant
    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)
    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)
    Evaluation of the Accuracy of Percutaneous Biopsy by Vacuum-assisted Biopsy (VAB) to Assess Pathological Complete Response in Patients With Clinical and Radiological Complete Response After Neoadjuvant Chemotherapy (NeoVAB) (NCT03876951)
    Phase N/A
    Centre Georges Francois Leclerc
    Active, not recruiting
    Last update posted :
    02/17/2025
    Initiation :
    08/30/2019
    Primary completion :
    02/28/2025
    Completion :
    04/08/2025
    ER
    |
    HER-2 positive • ER positive • ER negative
    A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (MORPHEUS BC) (NCT04802759)
    Phase 1/2
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    06/22/2021
    Primary completion :
    11/30/2027
    Completion :
    11/30/2027
    ER • CDK4
    |
    HER-2 positive • ER positive
    |
    Herceptin (trastuzumab) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • Kisqali (ribociclib) • ipatasertib (RG7440) • Itovebi (inavolisib) • giredestrant (GDC-9545) • Pegasys (pegylated interferon α -2a) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • samuraciclib (CT7001)
    Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer (NCT03598257)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/17/2025
    Initiation :
    01/18/2019
    Primary completion :
    06/01/2027
    Completion :
    06/01/2027
    ER • PGR • BRCA1 • BRCA2 • BRCA
    |
    BRCA mutation
    |
    Lynparza (olaparib)
    Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis (ASPIRE) (NCT03691493)
    Phase 2
    Emory University
    Completed
    Last update posted :
    02/17/2025
    Initiation :
    02/08/2019
    Primary completion :
    10/13/2022
    Completion :
    10/13/2022
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative • PGR positive
    |
    Ibrance (palbociclib) • fulvestrant • letrozole • anastrozole • exemestane • Soltamox (tamoxifen citrate)
    Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Patients With Estrogen Receptor Positive, HER2 Negative Breast Cancer (NCI-2018-01050) (NCT03774472)
    Phase 1/2
    M.D. Anderson Cancer Center
    Completed
    Last update posted :
    02/17/2025
    Initiation :
    08/20/2018
    Primary completion :
    04/17/2024
    Completion :
    04/17/2024
    HER-2 • ER
    |
    ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    Ibrance (palbociclib) • letrozole • hydroxychloroquine
    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)
    [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer (CAAA603B12101) (NCT05870579)
    Phase 1
    Novartis Pharmaceuticals
    Recruiting
    Last update posted :
    02/14/2025
    Initiation :
    11/13/2023
    Primary completion :
    12/30/2026
    Completion :
    01/26/2032
    HER-2 • ER
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Kisqali (ribociclib) • fulvestrant • goserelin acetate • AAA603
    'ADVANCE' (A Pilot Trial) (NCT03858322)
    Phase 1
    Dana-Farber Cancer Institute
    Active, not recruiting
    Last update posted :
    02/14/2025
    Initiation :
    03/21/2019
    Primary completion :
    11/10/2020
    Completion :
    06/30/2025
    HER-2 • ER
    |
    HR positive • HER-2 negative
    |
    carboplatin • paclitaxel • cyclophosphamide • cyclophosphamide intravenous
    Tamoxifen in Women With Breast Cancer and in Women at High-Risk of Breast Cancer Who Are Receiving Venlafaxine, Citalopram, Escitalopram, Gabapentin, or Sertraline (NCT00667121)
    Phase N/A
    Mayo Clinic
    Completed
    Last update posted :
    02/14/2025
    Initiation :
    03/16/2011
    Primary completion :
    05/12/2014
    Completion :
    05/27/2014
    ER
    |
    ER positive
    |
    tamoxifen • Soltamox (tamoxifen citrate)
    Letrozole or Tamoxifen Citrate in Treating Older Postmenopausal Women Undergoing Surgery for Breast Cancer (NCT00949598)
    Phase 3
    Institut du Cancer de Montpellier - Val d'Aurelle
    Completed
    Last update posted :
    02/13/2025
    Initiation :
    12/01/2008
    Primary completion :
    10/01/2010
    Completion :
    10/01/2010
    ER • PCNA
    |
    ER positive
    |
    tamoxifen • letrozole • Soltamox (tamoxifen citrate)
    Nadunolimab in Combination with Gemcitabine Plus Carboplatin in Patients with Advanced Triple Negative Breast Cancer. (TRIFOUR) (NCT05181462)
    Phase 1/2
    Cantargia AB
    Recruiting
    Last update posted :
    02/13/2025
    Initiation :
    01/11/2022
    Primary completion :
    06/15/2025
    Completion :
    08/01/2026
    HER-2 • PD-L1 • ER • PGR • BRCA1 • BRCA2 • BRCA
    |
    HER-2 negative • HER-2 negative + HR negative • HER-2 negative + HR negative + BRCA mutation
    |
    carboplatin • gemcitabine • nadunolimab (CAN04)