^
    15h
    DARLING-02: Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer （EBC） (clinicaltrials.gov)
    P2, N=144, Recruiting, Hebei Medical University Fourth Hospital | Trial completion date: Dec 2025 --> Dec 2028 | Trial primary completion date: Dec 2024 --> Dec 2026
    Trial completion date • Trial primary completion date • Head-to-Head
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    cyclophosphamide • epirubicin • AiRuiKang (dalpiciclib)
    19h
    Safety of CDK4/6 inhibitors in older patients: A FAERS-based analysis of serious and fatal adverse events. (PubMed, J Geriatr Oncol)
    Real-world data reveal drug- and age-specific toxicity differences. Ribociclib and abemaciclib pose higher risks in older adults compared to palbociclib, supporting the need for personalized treatment and careful monitoring in older patients.
    Journal • Adverse events
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
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    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib)
    1d
    High-Risk Node-Positive Hormone Receptor-Positive/HER2-Low Breast Cancer Relapse on Adjuvant Abemaciclib Treatment with ER Loss at Metastatic Recurrence: A Case Report and Literature Review. (PubMed, Diagnostics (Basel))
    Conversely, T-DXd administered due to the presence of HER2-low showed excellent effectiveness. Performing a re-biopsy is crucial due to the possible loss of estrogen receptors, which would require a change in therapeutic strategy no longer based on endocrine therapy. In cases that remain luminal, knowledge of the mutational profile may help to offer patients novel targeted treatments.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • RB1 (RB Transcriptional Corepressor 1)
    |
    HER-2 positive • HR positive • HER-2 negative • RB1 mutation • ESR1 mutation
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Verzenio (abemaciclib)
    2d
    Retrospective review of metastatic hormone receptor-positive inflammatory breast cancer patients reveals poor responses to cyclin dependent kinase 4/6 inhibition. (PubMed, Breast Cancer Res)
    Patients with metastatic HR+HER2- IBC demonstrated a shorter time on treatment suggesting shorter duration of response on CDKI + HT, which is markedly inferior to reported data for non-IBC patients from phase III trials.
    Retrospective data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR1 (Fibroblast growth factor receptor 1) • ARID1A (AT-rich interaction domain 1A) • CCND1 (Cyclin D1)
    |
    HER-2 positive • TP53 mutation • HR positive • HER-2 negative • PIK3CA mutation • ARID1A mutation • ESR1 mutation • HR positive + HER-2 negative • HER-2 negative + HR positive + ESR1 mutation
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib)
    2d
    MatchMel: Molecular Profiling and Matched Targeted Therapy for Patients With Unresectable Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P2, N=200, Completed, Melanoma Institute Australia | Active, not recruiting --> Completed | N=1000 --> 200 | Trial completion date: Dec 2028 --> Dec 2025
    Trial completion • Enrollment change • Trial completion date
    |
    Mekinist (trametinib) • pazopanib • Zykadia (ceritinib) • Kisqali (ribociclib)
    2d
    Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Dec 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    Ibrance (palbociclib) • fulvestrant
    3d
    PROSPERITY: A Prospective Observational Study to Describe Clinical Outcomes, Treatment Patterns, Patients Characteristics Among Patients With HR+/HER2- Advanced BC Initiating Treatment With Risarg®, Piqray®, Endocrine Therapy or Chemotherapy in Routine Clinical Practice in Russia (clinicaltrials.gov)
    P=N/A, N=2424, Completed, Novartis Pharmaceuticals | Recruiting --> Completed
    Trial completion
    |
    Piqray (alpelisib) • Kisqali (ribociclib)
    3d
    FUTURE: Aspects of Adjuvant CDK4/6 Inhibitors in Older Breast Cancer Patients - Focusing on Geriatric Screening (clinicaltrials.gov)
    P=N/A, N=200, Not yet recruiting, Region Jönköping County
    New trial • HEOR
    3d
    Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole (clinicaltrials.gov)
    P=N/A, N=42, Completed, Pfizer | N=28 --> 42
    Enrollment change
    |
    Ibrance (palbociclib) • letrozole
    4d
    Comparative cost-effectiveness of ribociclib and palbociclib as first-line treatment for HR+/HER2- advanced breast cancer in postmenopausal women: analysis from a Medicare perspective. (PubMed, J Med Econ)
    At a WTP threshold of $150,000 per evLY, ribociclib demonstrated an approximately 100% probability of being cost-effective relative to palbociclib. Ribociclib improved health outcomes with a minimal relative cost increase and is therefore a highly cost-effective 1 L treatment option vs. palbociclib in patients with HR+/HER2- aBC from the Medicare perspective.
    Clinical • Reimbursement • US reimbursement • Journal • HEOR • Medicare • Cost-effectiveness
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • Kisqali (ribociclib)
    4d
    Senescence-Primed Ferroptosis Enabled by a Metal-Organic Framework Nanoplatform for Enhanced Cancer Therapy. (PubMed, ACS Nano)
    To overcome these limitations, we propose a senescence-primed ferroptosis strategy using a metal-organic framework (MOF)-based nanoplatform (ZPG) that codelivers CDK4/6 inhibitor (palbociclib) and ferroptosis inducer (gallium ions, Ga3+) to enhance antitumor efficacy...Leveraging ZPG for the codelivery of therapeutic agents, the synergistic mechanism resulted in markedly enhanced antitumor efficacy both in vitro and in vivo, with minimal off-target toxicity. Collectively, the ZPG-enabled senescence-primed ferroptosis strategy provides a promising and mechanistically rational approach for improving cancer therapy.
    Journal
    |
    GPX4 (Glutathione Peroxidase 4) • ACSL4 (Acyl-CoA Synthetase Long Chain Family Member 4)
    |
    Ibrance (palbociclib)
    7d
    ValerEE: A Prospective NIS to Evaluate the Clinical Outcomes of Risarg® (Ribociclib) Combined With Endocrine Therapy or Chemotherapy in Patients With HR+HER2 - aBC in Routine Clinical Practice in the Russia (clinicaltrials.gov)
    P=N/A, N=376, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Kisqali (ribociclib)