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    DRUG CLASS:

    CDK4 inhibitor

    Related drugs:
    6d
    A Trial of HRS-6209-205 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Combination Therapy in Subjects With HR-Positive/HER2-Negative Cancer (clinicaltrials.gov)
    P1, N=15, Recruiting, Atridia Pty Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant • letrozole
    7d
    A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breast Cancer (clinicaltrials.gov)
    P1/2, N=80, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    letrozole • HRS-2189
    9d
    BGB-43395-102: BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=33, Completed, BeOne Medicines | Active, not recruiting --> Completed | Trial completion date: Oct 2026 --> Apr 2026
    Trial completion • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 negative
    |
    fulvestrant • letrozole
    23d
    A Study to Estimate Effect of Formulation and Food on Relative Bioavailability of HRS-6209 in Healthy Participants (clinicaltrials.gov)
    P1, N=21, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
    New P1 trial
    27d
    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, Recruiting, BeOne Medicines | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • letrozole
    1m
    FourLight-3: Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease (clinicaltrials.gov)
    P3, N=1035, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • letrozole • atirmociclib (PF-07220060)
    2ms
    BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=399, Recruiting, BeOne Medicines | N=300 --> 399 | Trial completion date: Jun 2028 --> Nov 2028 | Trial primary completion date: Jun 2028 --> Nov 2028
    Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    fulvestrant • letrozole • Orserdu (elacestrant)
    2ms
    FAIM: Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression (clinicaltrials.gov)
    P2, N=57, Active, not recruiting, Royal Marsden NHS Foundation Trust | Recruiting --> Active, not recruiting | N=324 --> 57 | Trial completion date: Sep 2026 --> Jun 2027 | Trial primary completion date: Sep 2026 --> Jun 2027
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 positive • ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • ipatasertib (RG7440) • Pegasys (pegylated interferon α -2a)
    2ms
    ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=65, Recruiting, Sarah Sammons, MD | Not yet recruiting --> Recruiting | Initiation date: Mar 2026 --> Nov 2025
    Enrollment open • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative • ESR1 mutation
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Orserdu (elacestrant)
    2ms
    TQB3616-II-04: Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=33, Active, not recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    |
    fulvestrant • Saitanxin (culmerciclib)
    2ms
    SIGNAL-ER 101: Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer (clinicaltrials.gov)
    P=N/A, N=725, Recruiting, Natera, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Signatera™
    2ms
    A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment. (clinicaltrials.gov)
    P3, N=400, Recruiting, Pfizer
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    everolimus • fulvestrant • exemestane • prifetrastat (PF-07248144)