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    DRUG CLASS:

    CDK4 inhibitor

    Related drugs:
    7d
    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
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
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    fulvestrant • letrozole • Orserdu (elacestrant)
    8d
    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)
    13d
    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)
    13d
    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)
    14d
    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™
    15d
    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)
    16d
    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
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    19d
    A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=180, Recruiting, Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    fulvestrant • letrozole
    19d
    A Study to Learn About How the Study Medicines Called Itraconazole and Probenecid Change How the Body Processes PF-07220060 (clinicaltrials.gov)
    P1, N=25, Completed, Pfizer | Recruiting --> Completed
    Trial completion
    |
    itraconazole • atirmociclib (PF-07220060)
    20d
    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
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Kisqali (ribociclib) • letrozole
    20d
    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
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    fulvestrant • Truqap (capivasertib) • zovegalisib (RLY-2608)
    24d
    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
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    ER positive • PIK3CA mutation • PGR positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • exemestane • tersolisib (LY4064809)