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    DRUG CLASS:

    CDK6 inhibitor

    Related drugs:
    21h
    A Study of Real-World Treatment Patterns and Outcomes Among HR+/HER2- Metastatic Breast Cancer Patients Treated With First-Line CDK4/6 Inhibitors (clinicaltrials.gov)
    P=N/A, N=480, Completed, Novartis Pharmaceuticals
    New trial • HEOR • Real-world evidence
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 negative
    5d
    SIE-3: A Study to Investigate the Efficacy and Safety of Letrozole SIE Compared With Femara® (Both Combined With the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women With HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=300, Not yet recruiting, Rovi Pharmaceuticals Laboratories | Trial completion date: Jun 2031 --> Dec 2033 | Initiation date: May 2026 --> Aug 2026
    Trial completion date • Trial initiation date
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
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    Kisqali (ribociclib) • letrozole
    5d
    ReDiscover-2: Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P3, N=540, Recruiting, Relay Therapeutics, Inc.
    Trial initiation date
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    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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    HER-2 negative • PIK3CA mutation
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    fulvestrant • Truqap (capivasertib) • zovegalisib (RLY-2608)
    9d
    PIKALO-2: A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) (clinicaltrials.gov)
    P3, N=193, Recruiting, Eli Lilly and Company
    New P3 trial
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
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    ER positive • PIK3CA mutation • PGR positive
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    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • exemestane • tersolisib (LY4064809)
    13d
    Assessment of flonoltinib maleate versus ruxolitinib phosphate in intermediate- to high-risk myelofibrosis (FMF-02): study protocol for a multicenter, randomized, open-label phase IIB trial. (PubMed, Ther Adv Hematol)
    The FMF-02 trial is the first randomized phase IIb study directly comparing the novel inhibitor FM against RUX. Its findings are expected to generate pivotal evidence regarding whether FM offers superior or differentiated clinical benefits, thereby informing its potential as a frontline therapy for intermediate- to high-risk MF and guiding the design of future phase III studies.
    P2b data • Journal
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    JAK2 (Janus kinase 2) • CDK6 (Cyclin-dependent kinase 6)
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    Jakafi (ruxolitinib) • flonoltinib
    13d
    J6M-MC-JSGD: A Study of LY4064809 With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) (2025-522791-92-00)
    P2/3, N=36, Not yet recruiting, Eli Lilly & Co.
    New P2/3 trial
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    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    ER positive • PIK3CA mutation
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    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • exemestane • tersolisib (LY4064809)
    13d
    BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease (clinicaltrials.gov)
    P3, N=1056, Not yet recruiting, BeOne Medicines
    New P3 trial
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 negative
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    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • letrozole
    14d
    Trilaciclib in Combination With Chemotherapy in Patients With CDK4/6-Dependent Solid Tumors (clinicaltrials.gov)
    P1, N=100, Recruiting, Hebei Medical University Fourth Hospital
    New P1 trial
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    Cosela (trilaciclib)
    14d
    Validation of Capillary Microsampling for Therapeutic Drug Monitoring of CDK4/6 Inhibitors in Breast Cancer Patients (TDHOME) (clinicaltrials.gov)
    P=N/A, N=90, Not yet recruiting, Institut Curie
    New trial
    15d
    Clinical and Pharmacoeconomic Assessment of CDK4/6 Inhibitors for Treatment of Breast Cancer in Egypt (clinicaltrials.gov)
    P4, N=206, Completed, Beni-Suef University
    New P4 trial • HEOR
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib)
    21d
    OBU-BC-II-164: 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 (clinicaltrials.gov)
    P2, N=100, Enrolling by invitation, Peking University | Not yet recruiting --> Enrolling by invitation
    Enrollment open
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    EndoPredict®
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    letrozole • AiRuiKang (dalpiciclib)
    25d
    OPERA-01: OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=510, Recruiting, Olema Pharmaceuticals, Inc. | N=370 --> 510
    Enrollment change
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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    HER-2 negative • ESR1 mutation
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    fulvestrant • letrozole • anastrozole • exemestane • palazestrant (OP-1250)