^
    3d
    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)
    3d
    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)
    5d
    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)
    12d
    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)
    12d
    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)
    24d
    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)
    1m
    A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer. (clinicaltrials.gov)
    P3, N=312, Recruiting, Risen (Suzhou) Pharma Tech Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    fulvestrant • AiRuiKang (dalpiciclib)
    1m
    SHR-A1811 Plus Pertuzumab as Neoadjuvant Therapy for Early or Locally Advanced HR-Positive HER2-Positive Breast Cancer: A Prospective, Open-Label, Phase II Study (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    Perjeta (pertuzumab) • Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811) • AiRuiKang (dalpiciclib)
    1m
    Case Report: Solitary scalp metastasis after surgery for invasive ductal carcinoma of the breast. (PubMed, Front Oncol)
    The patient was started on systemic therapy with fulvestrant plus dalpiciclib, and after four cycles, she achieved marked regression of the scalp lesion along with resolution of periorbital edema. Consequently, the patient received localized radiotherapy to these sites while continuing the original treatment protocol. This case highlights the diagnostic challenges of atypical scalp metastases in breast cancer and underscores the importance of early detection and prompt initiation of comprehensive treatment.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 expression • EGFR positive
    |
    fulvestrant • AiRuiKang (dalpiciclib)
    2ms
    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)
    2ms
    Dalpiciclib Plus Camrelizumab for HCC Patients Who Have Previously Received ICI Treatment (clinicaltrials.gov)
    P2, N=30, Recruiting, Sun Yat-sen University
    New P2 trial • Checkpoint inhibition
    |
    AiRuiKa (camrelizumab) • AiRuiKang (dalpiciclib)
    3ms
    Clinical Study of Fluzoparib Combined with Dalpiciclib and Endocrine Neoadjuvant Therapy for gBRCA-Mutated HR+/HER2- Early-Stage Breast Cancer (ChiCTR2500110867)
    P=N/A, N=30, Not yet recruiting, Harbin Medical University Affiliated Cancer Hospital; Harbin Medical University Affiliated Cancer Hospital
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    HR positive • HER-2 negative
    |
    letrozole • anastrozole • exemestane • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib)