^
    Apply
    First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors (STX-478-101) (NCT05768139)
    Phase 1/2
    Scorpion Therapeutics, Inc.
    Recruiting
    Last update posted :
    02/21/2025
    Initiation :
    04/17/2023
    Primary completion :
    02/28/2027
    Completion :
    02/28/2029
    PIK3CA
    |
    PIK3CA mutation
    |
    Ibrance (palbociclib) • Kisqali (ribociclib) • fulvestrant • STX-478
    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)
    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)
    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 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)
    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
    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)
    [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
    TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B) (TACTIVE-U Sub-Study B) (NCT05573555)
    Phase 1/2
    Pfizer
    Recruiting
    Last update posted :
    02/11/2025
    Initiation :
    03/01/2023
    Primary completion :
    12/30/2026
    Completion :
    12/30/2026
    HER-2
    |
    HER-2 negative
    |
    Kisqali (ribociclib) • vepdegestrant (ARV-471)
    A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (Morpheus-TNBC) (NCT03424005)
    Phase 1/2
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/10/2025
    Initiation :
    03/30/2018
    Primary completion :
    05/03/2028
    Completion :
    05/03/2028
    HER-2 • PD-L1 • PIK3CA
    |
    PD-L1 expression • PIK3CA mutation
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • Verzenio (abemaciclib) • albumin-bound paclitaxel • Kisqali (ribociclib) • fulvestrant • Halaven (eribulin mesylate) • letrozole • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Itovebi (inavolisib) • Actemra IV (tocilizumab) • ladiratuzumab vedotin (SGN-LIV1A) • selicrelumab (RG7876)
    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)
    Study of AVZO-021 in Patients with Advanced Solid Tumors (ARTS-021-1001) (NCT05867251)
    Phase 1/2
    Avenzo Therapeutics, Inc.
    Recruiting
    Last update posted :
    02/05/2025
    Initiation :
    08/30/2023
    Primary completion :
    01/31/2028
    Completion :
    01/31/2030
    HER-2 • CCNE1
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • carboplatin • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • Trodelvy (sacituzumab govitecan-hziy) • AVZO-021
    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)
    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
    First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, As a Single Agent in Advanced Solid Tumor Patients and in Combination with Fulvestrant in Patients with Advanced Breast Cancer (ReDiscover) (NCT05216432)
    Phase 1
    Relay Therapeutics, Inc.
    Recruiting
    Last update posted :
    01/29/2025
    Initiation :
    12/08/2021
    Primary completion :
    12/31/2025
    Completion :
    08/31/2026
    HER-2 • PIK3CA • BRCA1 • BRCA2
    |
    HER-2 negative • PIK3CA mutation
    |
    Ibrance (palbociclib) • Piqray (alpelisib) • Kisqali (ribociclib) • fulvestrant • RLY-2608 • atirmociclib (PF-07220060)
    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)
    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)
    Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) (NCT06757634)
    Phase 3
    Celcuity Inc
    Not yet recruiting
    Last update posted :
    01/07/2025
    Initiation :
    06/30/2025
    Primary completion :
    12/31/2027
    Completion :
    12/30/2028
    PIK3CA
    |
    Ibrance (palbociclib) • Kisqali (ribociclib) • fulvestrant • gedatolisib (PF-05212384)
    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
    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)
    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
    Ribociclib and Bicalutamide in AR+ TNBC (NCT03090165)
    Phase 1/2
    Kari Wisinski
    Recruiting
    Last update posted :
    10/11/2024
    Initiation :
    05/07/2018
    Primary completion :
    09/01/2025
    Completion :
    09/01/2025
    HER-2 • ER • AR
    |
    HER-2 negative • AR positive • HER-2 negative + ER positive
    |
    Kisqali (ribociclib) • bicalutamide
    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)
    FACILE: FeAsibility of First-line riboCIclib in oLdEr Patients With Advanced Breast Cancer (NCT03944434)
    Phase 2
    Fondazione Sandro Pitigliani
    Active, not recruiting
    Last update posted :
    09/25/2024
    Initiation :
    12/27/2018
    Primary completion :
    12/27/2024
    Completion :
    11/27/2025
    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) • letrozole • anastrozole • triptorelin • goserelin acetate • leuprolide acetate for depot suspension
    Neoadjuvant Treatment of Locally-advanced Breast Cancer Patients With Ribociclib and Letrozole (NEOLETRIB) (NCT05163106)
    Phase 2
    University Hospital, Akershus
    Completed
    Last update posted :
    08/02/2024
    Initiation :
    12/01/2022
    Primary completion :
    07/30/2024
    Completion :
    07/30/2024
    HER-2 • ER
    |
    ER positive • HER-2 negative
    |
    Kisqali (ribociclib) • letrozole • goserelin acetate
    Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma (NCT04417621)
    Phase 2
    Novartis Pharmaceuticals
    Active, not recruiting
    Last update posted :
    06/11/2024
    Initiation :
    10/30/2020
    Primary completion :
    08/30/2024
    Completion :
    09/30/2024
    BRAF • NRAS
    |
    NRAS mutation • BRAF V600
    |
    Mekinist (trametinib) • Kisqali (ribociclib) • naporafenib (ERAS-254) • rineterkib (LTT462)
    Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) (NCT04862663)
    Phase 3
    AstraZeneca
    Recruiting
    Last update posted :
    06/06/2024
    Initiation :
    05/10/2021
    Primary completion :
    11/01/2027
    Completion :
    08/14/2029
    HER-2 • ER • PGR
    |
    HER-2 negative • PGR expression
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • Truqap (capivasertib)
    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)
    DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs). (NCT02035813)
    Phase 2
    Prof. Wolfgang Janni
    Completed
    Last update posted :
    06/04/2024
    Initiation :
    01/01/2014
    Primary completion :
    01/10/2024
    Completion :
    01/10/2024
    ER • PGR
    |
    ER positive • HR positive • HR negative • PGR positive
    |
    Kisqali (ribociclib) • Halaven (eribulin mesylate)
    Detect V / CHEVENDO (Chemo vs. Endo) (DETECT V) (NCT02344472)
    Phase 3
    Prof. Wolfgang Janni
    Active, not recruiting
    Last update posted :
    06/04/2024
    Initiation :
    09/01/2015
    Primary completion :
    01/31/2025
    Completion :
    01/31/2025
    HER-2
    |
    HER-2 positive • HR positive
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • capecitabine • albumin-bound paclitaxel • Kisqali (ribociclib) • fulvestrant • Halaven (eribulin mesylate) • letrozole • vinorelbine tartrate • anastrozole • exemestane • goserelin acetate • leuprolide acetate for depot suspension
    SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors (NCT03434262)
    Phase 1
    St. Jude Children's Research Hospital
    Completed
    Last update posted :
    05/31/2024
    Initiation :
    03/05/2018
    Primary completion :
    09/30/2022
    Completion :
    05/24/2024
    PTCH1
    |
    PTCH1 mutation
    |
    Mekinist (trametinib) • gemcitabine • Kisqali (ribociclib) • Odomzo (sonidegib) • Neupogen (filgrastim)
    Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer. (NCT03671330)
    Phase 2
    Novartis Pharmaceuticals
    Active, not recruiting
    Last update posted :
    05/21/2024
    Initiation :
    08/29/2018
    Primary completion :
    04/25/2022
    Completion :
    04/15/2025
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative • PGR positive
    |
    Kisqali (ribociclib) • letrozole • anastrozole • goserelin acetate
    A Study of Ribociclib in Combination With Hormonal Therapy in HR+/HER2- Advanced or Metastatic Breast Cancer (NCT06075758)
    Phase N/A
    Novartis Pharmaceuticals
    Recruiting
    Last update posted :
    05/21/2024
    Initiation :
    03/07/2024
    Primary completion :
    11/30/2024
    Completion :
    11/30/2024
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative • PGR positive
    |
    Kisqali (ribociclib)
    A Phase 0 /II Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection (NCT03834740)
    Phase 1
    St. Joseph's Hospital and Medical Center, Phoenix
    Completed
    Last update posted :
    05/10/2024
    Initiation :
    12/21/2018
    Primary completion :
    02/18/2022
    Completion :
    02/18/2022
    PIK3CA • PTEN • CDKN2A • mTOR • CCND1 • CCNE1 • CDK4 • CDKN2B • PIK3R1 • CASP3 • FOXM1 • PIK3C2B
    |
    PIK3CA mutation • CCND1 amplification • CDK4 amplification • MTOR mutation • CCND1 expression • PIK3CA mutation + PTEN mutation • PIK3R1 mutation • CCNE1 expression
    |
    everolimus • Kisqali (ribociclib)
    A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer (RibOB) (NCT03956654)
    Phase N/A
    Universitaire Ziekenhuizen KU Leuven
    Active, not recruiting
    Last update posted :
    05/08/2024
    Initiation :
    12/11/2018
    Primary completion :
    12/31/2022
    Completion :
    06/30/2024
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative • PGR positive
    |
    Kisqali (ribociclib) • letrozole
    Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer (CLEE011X2107) (NCT01872260)
    Phase 1/2
    Novartis Pharmaceuticals
    Active, not recruiting
    Last update posted :
    05/07/2024
    Initiation :
    10/22/2013
    Primary completion :
    12/31/2024
    Completion :
    12/31/2024
    ER • PGR
    |
    ER positive • PGR positive
    |
    Piqray (alpelisib) • Kisqali (ribociclib) • letrozole
    Study to Determine the Safety and Efficacy of Ribociclib in Combination With Hormone Therapy and Hypofractionated Radiotherapy in Breast Cancer, With Positive Hormone Receptors and Negative HER2 Status, in Newly Diagnosed, Not Immediately Operable Elderly Patient (CALHYS) (NCT05664893)
    Phase 1/2
    Centre Antoine Lacassagne
    Recruiting
    Last update posted :
    05/06/2024
    Initiation :
    06/26/2023
    Primary completion :
    10/01/2031
    Completion :
    03/01/2033
    HER-2
    |
    Kisqali (ribociclib)
    Phase IIIb Study of Ribociclib + ET in Early Breast Cancer (ADJUVANT WIDER) (NCT05827081)
    Phase 3
    Novartis Pharmaceuticals
    Suspended
    Last update posted :
    04/24/2024
    Initiation :
    02/28/2024
    Primary completion :
    09/07/2029
    Completion :
    09/20/2030
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative • PGR positive
    |
    Kisqali (ribociclib) • letrozole • exemestane • goserelin acetate • leuprolide acetate for depot suspension
    (VELA) Study of BLU-222 in Advanced Solid Tumors (NCT05252416)
    Phase 1/2
    Blueprint Medicines Corporation
    Recruiting
    Last update posted :
    04/23/2024
    Initiation :
    04/07/2022
    Primary completion :
    11/30/2025
    Completion :
    09/30/2026
    HER-2 • CCNE1
    |
    HER-2 negative • CCNE1 amplification
    |
    carboplatin • Kisqali (ribociclib) • fulvestrant • BLU-222