^
    9d
    CDK4/6 Inhibitors Intensification for Chemotherapy Omission in Small Size High-risk ER-positive Breast Cancer（Cinnamon） (clinicaltrials.gov)
    P3, N=2288, Not yet recruiting, Fudan University
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 positive • ER positive • HER-2 negative • HER-2 expression • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    Oncotype DX Breast Recurrence Score®Test
    |
    docetaxel • cyclophosphamide • AiRuiKang (dalpiciclib)
    12d
    Adebrelimab in combination with dalpiciclib and endocrine therapy as neoadjuvant treatment for HR+/HER2- early breast cancer: an exploratory study. (PubMed, Int J Surg)
    This triplet regimen demonstrated modest clinical activity in HR+/HER2- early BC, with the safety profile of this regimen remains a concern and warrants particular attention in clinical practice.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    letrozole • AiRuiKang (dalpiciclib) • AiRuiLi (adebrelimab)
    22d
    Cyclin-Dependent 4/6 Kinase Inhibitors for Treatment of HER2-Positive Breast Cancer: 2026 Update. (PubMed, Cancers (Basel))
    Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i; palbociclib, ribociclib, abemaciclib, dalpiciclib) combined with endocrine therapy (ET) were a major advance in the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) worldwide...However, clinical development of CDK4/6i in HER2+ MBC slowed, given the advent of highly effective tyrosine-kinase inhibitors (TKIs) (i.e., tucatinib) and antibody-drug conjugates (ADCs) (i.e., trastuzumab deruxtecan), which currently dominate the treatment armamentarium...Subsequently, the phase III PATINA trial (which included patients with 1L HR+HER2+ MBC, treated with palbociclib vs. placebo with maintenance ET+ H[P]) noted a striking PFS improvement of >15 months in the palbociclib arm, renewing interest in CDK4/6i-based treatments for HR+HER2+ MBC. Herein, we review the development of CDK4/6i in HER2+ BC, discussing current challenges and potential future directions.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    Ibrance (palbociclib) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Verzenio (abemaciclib) • Kisqali (ribociclib) • Tukysa (tucatinib) • AiRuiKang (dalpiciclib)
    23d
    Real-world efficacy and prognostic factors of CDK4/6 inhibitors in HR+/HER2- metastatic breast cancer: a multicenter retrospective study from the Dongting Lake region of China. (PubMed, Transl Breast Cancer Res)
    The most commonly used CDK4/6i were abemaciclib (33.39%), dalpiciclib (28.98%), palbociclib (25.76%), and ribociclib (10.85%). CDK4/6i demonstrates favorable real-world efficacy in HR+/HER2- MBC patients in central China, particularly in the first-line setting. Several clinical factors may aid in treatment selection and risk stratification.
    Retrospective data • Journal • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • EGFR positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • AiRuiKang (dalpiciclib)
    24d
    Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients (clinicaltrials.gov)
    P2/3, N=119, Completed, Tianjin Medical University Cancer Institute and Hospital | Recruiting --> Completed | Trial completion date: Sep 2026 --> Sep 2025
    Trial completion • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 expression
    |
    cyclophosphamide • epirubicin • exemestane • AiRuiKang (dalpiciclib) • goserelin acetate
    1m
    Dalpiciclib in HR+/HER2- ABC (clinicaltrials.gov)
    P=N/A, N=103, Recruiting, RenJi Hospital | Trial primary completion date: Dec 2025 --> Jan 2027
    Trial primary completion date • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    AiRuiKang (dalpiciclib)
    1m
    Efficacy and safety of Dalpiciclib in the treatment of hormone receptor-positive advanced breast cancer a multicenter observational real-world study (ChiCTR2500114023)
    P=N/A, N=500, Recruiting, Harbin Medical University Affiliated Cancer Hospital; Harbin Medical University Affiliated Cancer Hospital
    New trial
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • PGR positive
    |
    AiRuiKang (dalpiciclib)
    1m
    An Open-Label, Randomized Controlled, Phase III Study of Dalpiciclib Plus Endocrine Therapy Versus Chemotherapy Followed by Endocrine Therapy in High-Risk HR+/HER2- Recurrent or Metastatic Breast Cancer (ChiCTR2500113953)
    P4, N=220, Not yet recruiting, Cancer Hospital of Shandong First Medical University; Cancer Hospital of Shandong First Medical University
    New P4 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    AiRuiKang (dalpiciclib)
    1m
    The synergistic tumor suppressor effect of CDK4/6 inhibitors and BRD4 inhibitors in acute myeloid leukemia. (PubMed, Leuk Res Rep)
    5. SHR6390 and OTX015 Synergistically Inhibit the Growth of AML Xenografts In Vivo.
    Journal
    |
    BRD4 (Bromodomain Containing 4)
    |
    AiRuiKang (dalpiciclib) • birabresib (OTX015)
    1m
    A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy. (clinicaltrials.gov)
    P3, N=912, Not yet recruiting, Shandong Suncadia Medicine Co., Ltd.
    New P3 trial
    |
    fulvestrant • AiRuiKang (dalpiciclib)
    1m
    DNADalHR: ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=393, Recruiting, Peking University People's Hospital | Not yet recruiting --> Recruiting
    Enrollment open • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    paclitaxel • docetaxel • cyclophosphamide • exemestane • AiRuiKang (dalpiciclib)
    2ms
    Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=146, Recruiting, Shandong Suncadia Medicine Co., Ltd. | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Oct 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    AiRuiKang (dalpiciclib)