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    Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas (NCT04750928)
    Phase 1/2
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/24/2025
    Initiation :
    11/29/2021
    Primary completion :
    12/31/2028
    Completion :
    12/31/2029
    NF1
    |
    NF1 mutation
    |
    Verzenio (abemaciclib)
    Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial (NCT05554367)
    Phase 2
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/20/2025
    Initiation :
    12/13/2023
    Primary completion :
    08/26/2026
    Completion :
    08/26/2026
    KRAS • BRAF • NRAS • HRAS • RAS
    |
    BRAF V600E • KRAS mutation • KRAS G12C • HRAS mutation • KRAS G12
    |
    Ibrance (palbociclib) • Mektovi (binimetinib)
    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)
    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
    Study of Ribociclib and Everolimus in HGG and DIPG (NCT05843253)
    Phase 2
    Nationwide Children's Hospital
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    08/22/2024
    Primary completion :
    08/28/2028
    Completion :
    08/28/2034
    PIK3CA • PTEN • CDKN2A • RB1 • CCND1 • CDK4 • CDKN2B • PIK3R1 • CDK6 • CCND2 • CDKN2C
    |
    PIK3CA mutation • CDKN2A deletion
    |
    everolimus • Kisqali (ribociclib)
    A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence (CAROLEEN) (NCT06830720)
    Phase N/A
    Novartis Pharmaceuticals
    Not yet recruiting
    Last update posted :
    02/17/2025
    Initiation :
    02/09/2025
    Primary completion :
    05/31/2030
    Completion :
    05/31/2030
    HER-2
    |
    HER-2 negative
    |
    Verzenio (abemaciclib) • Kisqali (ribociclib)
    Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors (NCT05429502)
    Phase 1/2
    Novartis Pharmaceuticals
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    12/27/2022
    Primary completion :
    10/15/2027
    Completion :
    01/28/2028
    MYCN • SMARCB1
    |
    IDH wild-type
    |
    temozolomide • Kisqali (ribociclib) • topotecan
    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
    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)
    [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
    PALbociclib CoLlaborative Adjuvant Study (PALLAS) (NCT02513394)
    Phase 3
    Alliance Foundation Trials, LLC.
    Active, not recruiting
    Last update posted :
    02/14/2025
    Initiation :
    08/01/2015
    Primary completion :
    11/01/2020
    Completion :
    12/01/2028
    HER-2 • PGR
    |
    HER-2 negative
    |
    Ibrance (palbociclib)
    Determinants of Resistance to Endocrine Therapy and a Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor for HR+ MBC (NCT03439735)
    Phase 2
    Sidney Kimmel Comprehensive Cancer Center at Jo...
    Recruiting
    Last update posted :
    02/13/2025
    Initiation :
    07/20/2018
    Primary completion :
    08/01/2025
    Completion :
    11/01/2025
    HER-2 • ER • PGR
    |
    HER-2 negative
    |
    Ibrance (palbociclib)
    Endocrine Therapy Fulvestrant & Palbociclib or Aromatase Inhibitor Therapy in Treating Older Patients with Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery (NCT02760030)
    Phase 2
    Ohio State University Comprehensive Cancer Center
    Active, not recruiting
    Last update posted :
    02/12/2025
    Initiation :
    02/16/2017
    Primary completion :
    07/31/2025
    Completion :
    07/31/2025
    HER-2 • ER • PGR
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • fulvestrant
    Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation (NCI-2018-01218) (NCT03065387)
    Phase 1
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    02/10/2025
    Initiation :
    10/31/2017
    Primary completion :
    10/01/2025
    Completion :
    10/01/2025
    HER-2 • KRAS • ERBB3 • ERBB4
    |
    KRAS mutation • EGFR mutation • HER-2 amplification • EGFR amplification
    |
    Mekinist (trametinib) • Ibrance (palbociclib) • everolimus • Nerlynx (neratinib)
    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)
    WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor (NCT03854903)
    Phase 1
    Georgetown University
    Completed
    Last update posted :
    02/06/2025
    Initiation :
    04/01/2019
    Primary completion :
    11/01/2023
    Completion :
    01/09/2025
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    Ibrance (palbociclib) • fulvestrant • Bosulif (bosutinib)
    Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors (NCI-2022-04099) (NCT05372640)
    Phase 1
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/05/2025
    Initiation :
    08/10/2023
    Primary completion :
    06/01/2025
    Completion :
    06/01/2025
    NUTM1
    |
    Verzenio (abemaciclib) • ZEN-3694
    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)
    Evaluation of Abemaciclib and Radiation Therapy Before Surgery for the Treatment of High-Risk Adipocytic Retroperitoneal Sarcoma (NCT06025747)
    Phase 1
    Fred Hutchinson Cancer Center
    Recruiting
    Last update posted :
    02/04/2025
    Initiation :
    02/09/2025
    Primary completion :
    03/03/2025
    Completion :
    03/03/2026
    MDM2 • CDK4
    |
    CDK4 amplification
    |
    Verzenio (abemaciclib)
    Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma (NCT02159755)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/04/2025
    Initiation :
    05/20/2014
    Primary completion :
    06/25/2018
    Completion :
    01/20/2026
    CCND1 • CD5
    |
    Chr t(11;14)
    |
    Ibrance (palbociclib) • Imbruvica (ibrutinib)
    Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer (NCT03939897)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/04/2025
    Initiation :
    06/17/2020
    Primary completion :
    06/22/2023
    Completion :
    07/16/2025
    HER-2 • ER • PIK3CA • PGR • PTEN
    |
    HER-2 amplification • HER-2 negative • PGR positive
    |
    Verzenio (abemaciclib) • fulvestrant • Aliqopa (copanlisib)
    Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer (RIBOLARIS) (NCT05296746)
    Phase 2
    SOLTI Breast Cancer Research Group
    Recruiting
    Last update posted :
    02/04/2025
    Initiation :
    05/03/2022
    Primary completion :
    10/01/2029
    Completion :
    12/01/2031
    HER-2 • ER
    |
    HER-2 positive • ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    docetaxel • doxorubicin hydrochloride • cyclophosphamide • Kisqali (ribociclib)
    Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer (ToPCourT) (NCT06027268)
    Phase 2
    Wake Forest University Health Sciences
    Recruiting
    Last update posted :
    02/04/2025
    Initiation :
    01/10/2024
    Primary completion :
    09/01/2026
    Completion :
    03/01/2027
    HER-2 • PD-L1
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • carboplatin • gemcitabine • Cosela (trilaciclib)
    Ribociclib and Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR) (NCT05467891)
    Phase 2
    Oana Danciu
    Recruiting
    Last update posted :
    01/31/2025
    Initiation :
    09/13/2022
    Primary completion :
    08/01/2028
    Completion :
    08/01/2029
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    tamoxifen • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • exemestane
    Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib (SAFIR 03) (NCT05625087)
    Phase 2
    UNICANCER
    Recruiting
    Last update posted :
    01/30/2025
    Initiation :
    10/19/2023
    Primary completion :
    07/01/2028
    Completion :
    06/01/2030
    HER-2 • ER • PIK3CA • PGR
    |
    HR positive • HER-2 overexpression • HER-2 negative • PIK3CA mutation • HER-2 overexpression + HR positive
    |
    Piqray (alpelisib) • Kisqali (ribociclib) • fulvestrant • triptorelin
    A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (INAVO121) (NCT05646862)
    Phase 3
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    01/29/2025
    Initiation :
    06/07/2023
    Primary completion :
    03/30/2029
    Completion :
    03/30/2029
    HER-2 • PIK3CA • CDK4
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant • Itovebi (inavolisib)
    Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor (NCT04966481)
    Phase 3
    Washington University School of Medicine
    Recruiting
    Last update posted :
    01/29/2025
    Initiation :
    04/06/2022
    Primary completion :
    02/28/2027
    Completion :
    02/28/2027
    CDKN2A
    |
    CDKN2A negative
    |
    Erbitux (cetuximab) • Ibrance (palbociclib)
    Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer (NCT02778685)
    Phase 2
    City of Hope Medical Center
    Active, not recruiting
    Last update posted :
    01/29/2025
    Initiation :
    09/30/2016
    Primary completion :
    03/30/2026
    Completion :
    03/30/2026
    HER-2 • ER
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • Ibrance (palbociclib) • fulvestrant • letrozole
    Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases (MCC-20899) (NCT04923542)
    Phase 1/2
    H. Lee Moffitt Cancer Center and Research Insti...
    Recruiting
    Last update posted :
    01/29/2025
    Initiation :
    11/30/2021
    Primary completion :
    03/01/2025
    Completion :
    03/01/2026
    HER-2 • ER • PGR
    |
    HER-2 overexpression • HER-2 negative
    |
    Verzenio (abemaciclib) • fulvestrant
    RWE Non-Interventional Prospective Study of Ribociclib Effectiveness and Safety in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia (NISLEESA) (NCT06797531)
    Phase N/A
    Novartis Pharmaceuticals
    Not yet recruiting
    Last update posted :
    01/28/2025
    Initiation :
    03/31/2025
    Primary completion :
    11/30/2028
    Completion :
    11/30/2028
    HER-2
    |
    HER-2 negative
    |
    Kisqali (ribociclib)
    A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer (KEYNOTE 287) (NCT02779751)
    Phase 1
    Eli Lilly and Company
    Active, not recruiting
    Last update posted :
    01/24/2025
    Initiation :
    11/14/2016
    Primary completion :
    02/03/2020
    Completion :
    12/01/2025
    HER-2 • PD-L1 • KRAS
    |
    KRAS mutation
    |
    Keytruda (pembrolizumab) • Verzenio (abemaciclib) • anastrozole
    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)
    Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC (ADAPTcycle) (NCT04055493)
    Phase 3
    West German Study Group
    Active, not recruiting
    Last update posted :
    01/14/2025
    Initiation :
    07/02/2019
    Primary completion :
    07/31/2027
    Completion :
    07/31/2027
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    Kisqali (ribociclib)
    Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (PATINA) (NCT02947685)
    Phase 3
    Alliance Foundation Trials, LLC.
    Active, not recruiting
    Last update posted :
    01/13/2025
    Initiation :
    06/21/2017
    Primary completion :
    10/15/2024
    Completion :
    07/31/2026
    PIK3CA • PGR
    |
    HER-2 positive • HR positive • PIK3CA mutation
    |
    Herceptin (trastuzumab) • Ibrance (palbociclib) • Perjeta (pertuzumab) • fulvestrant • letrozole • anastrozole • exemestane
    To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH) (NCT03644186)
    Phase 2
    ETOP IBCSG Partners Foundation
    Completed
    Last update posted :
    12/13/2024
    Initiation :
    04/16/2019
    Primary completion :
    01/03/2023
    Completion :
    04/14/2023
    HER-2 • ER
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Ibrance (palbociclib) • paclitaxel • Perjeta (pertuzumab) • letrozole
    Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer (MAINTAIN) (NCT02632045)
    Phase 2
    Melissa K Accordino
    Completed
    Last update posted :
    12/06/2024
    Initiation :
    03/01/2016
    Primary completion :
    01/04/2022
    Completion :
    01/04/2022
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative
    |
    Kisqali (ribociclib) • fulvestrant
    A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer (TRAK-ER) (NCT04985266)
    Phase 2
    Royal Marsden NHS Foundation Trust
    Recruiting
    Last update posted :
    12/05/2024
    Initiation :
    03/30/2022
    Primary completion :
    09/01/2027
    Completion :
    09/01/2030
    HER-2
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • tamoxifen • fulvestrant • letrozole • anastrozole • exemestane
    Palbociclib and Pembrolizumab in Central Nervous System Metastases (NCT02896335)
    Phase 2
    Massachusetts General Hospital
    Recruiting
    Last update posted :
    11/21/2024
    Initiation :
    02/02/2017
    Primary completion :
    09/01/2025
    Completion :
    09/01/2026
    CDKN2A • CCND1 • CCNE1 • CDK4 • CDK6 • CCND2 • CCND3
    |
    CCNE1 amplification • CCND1 amplification • CDK4 amplification
    |
    Keytruda (pembrolizumab) • Ibrance (palbociclib)
    Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics (CHARGE) (NCT04315233)
    Phase 1
    University of Utah
    Recruiting
    Last update posted :
    10/30/2024
    Initiation :
    05/03/2021
    Primary completion :
    04/01/2024
    Completion :
    08/01/2026
    HER-2
    |
    HER-2 negative
    |
    Kisqali (ribociclib) • Beleodaq (belinostat)
    Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer (OBU-BC-II-164) (NCT06650748)
    Phase 2
    Peking University
    Not yet recruiting
    Last update posted :
    10/26/2024
    Initiation :
    11/15/2024
    Primary completion :
    10/01/2027
    Completion :
    04/01/2028
    CDK4
    |
    letrozole • AiRuiKang (dalpiciclib)
    Ribociclib in Combination With Everolimus and Dexamethasone in Relapsed ALL (NCT03740334)
    Phase 1
    Dana-Farber Cancer Institute
    Active, not recruiting
    Last update posted :
    10/24/2024
    Initiation :
    01/30/2019
    Primary completion :
    03/04/2023
    Completion :
    04/01/2025
    ABL1 • BCR
    |
    everolimus • Kisqali (ribociclib) • dexamethasone