^
    3d
    Optimizing axillary lymph node management in early-stage HR+/HER2- breast cancer: Practical strategies for enhanced detection rates. (PubMed, Breast)
    Optimized staging and risk assessment in HR+/HER2- EBC is critical to identify high-risk patients eligible for CDK4/6 inhibitors. Implementing these recommendations may improve patient outcomes in the adjuvant setting.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Verzenio (abemaciclib)
    4d
    Observational Study of Gut Microbiota in Abemaciclib-Treated Patients With and Without Diarrhea (clinicaltrials.gov)
    P=N/A, N=60, Recruiting, Hubei Cancer Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HR positive
    |
    Verzenio (abemaciclib)
    5d
    Mirdametinib and abemaciclib cooperate in atypical teratoid rhabdoid tumor to decrease proliferation and suppress tumor growth. (PubMed, bioRxiv)
    Mirdametinib and abemaciclib combined to extend survival of mice bearing orthotopic ATRT xenografts. In conclusion, mirdametinib has single agent activity against ATRT and combines with abemaciclib to decrease proliferation and extend survival in orthotopic xenograft models of ATRT.
    Journal
    |
    ANXA5 (Annexin A5)
    |
    Verzenio (abemaciclib) • Gomekli (mirdametinib)
    6d
    INX-315-01: Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer (clinicaltrials.gov)
    P1/2, N=150, Recruiting, Incyclix Bio | Trial completion date: Jun 2026 --> Sep 2027 | Trial primary completion date: Dec 2025 --> Jul 2027
    Trial completion date • Trial primary completion date • First-in-human
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Verzenio (abemaciclib) • fulvestrant • INX-315
    6d
    Metabolic Response to CDK4/6 Inhibition in ER+ Breast Cancer Creates a Therapeutic Vulnerability in Drug-Tolerant Persister Cells. (PubMed, FASEB J)
    Inhibition of mitochondrial complex I further increased ROS levels and enhanced growth inhibition in both endocrine-sensitive and -resistant cell lines and patient-derived xenografts. These findings collectively offer mitochondrial respiration as a therapeutic target in CDK4/6-tolerant persister breast cancer cells to help eradicate residual disease.
    Journal
    |
    ER (Estrogen receptor)
    |
    ER positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib)
    7d
    Abemaciclib plus fulvestrant in treating hormone-receptor positive, HER2-negative advanced breast cancer-comparing real-world outcomes in England to the MONARCH-2 trial. (PubMed, Br J Cancer)
    MONARCH-2 trial data are not generalisable to this real-world cohort, which had notably shorter OS, TFS and CFS that could not be explained by differences in measured patient characteristics.
    Journal • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Verzenio (abemaciclib) • fulvestrant
    7d
    A Retrospective Observational Study of Safety and Effectiveness of Abemaciclib in Chinese Patients with Breast Cancer. (PubMed, Adv Ther)
    In this largest real-world study of abemaciclib in China to date, abemaciclib was well tolerated with no new safety signals, and its effectiveness was consistent with prior trials, confirming its positive benefit-risk profile in real-world settings.
    Observational data • Retrospective data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • EGFR positive
    |
    Verzenio (abemaciclib)
    7d
    Lilly-I3Y-US-I026: Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer (clinicaltrials.gov)
    P1/2, N=5, Terminated, Criterium, Inc. | N=44 --> 5 | Recruiting --> Terminated; Study was terminated due to delayed recruitment.
    Enrollment change • Trial termination
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    Verzenio (abemaciclib) • Orserdu (elacestrant)
    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
    |
    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)
    10d
    Incidence and outcomes of atrial arrhythmia with cyclin dependent kinase 4/6 inhibitors in hormone receptor-positive / human epidermal growth factor receptor 2-negative breast cancer. (PubMed, Int J Cardiol)
    Patients who receive CDK4/6 inhibitors for breast cancer experience a low but measurable risk of new-onset atrial arrhythmias. There was no significant difference in new-onset AA risk between agents. Prospective studies are needed to define mechanisms and guide monitoring strategies.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • EGFR positive • HR positive + HER-2 negative
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib)
    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
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    ER positive • PIK3CA mutation
    |
    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
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • letrozole