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    14d
    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
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    AiRuiKa (camrelizumab) • AiRuiKang (dalpiciclib)
    1m
    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
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    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
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    HR positive • HER-2 negative
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    letrozole • anastrozole • exemestane • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib)
    1m
    An Exploratory Study of Concurrent or Sequential Radiotherapy Combined with Dalpiciclib plus Endocrine Therapy in Early-Stage or Locoregionally Advanced Hormone Receptor-Positive/HER2-Negative Breast Cancer (ChiCTR2500109355)
    P2, N=200, Not yet recruiting, Shanxi Cancer Hospital; Shanxi Cancer Hospital
    New P2 trial
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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    HR positive • HER-2 negative • HR positive + HER-2 negative
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    AiRuiKang (dalpiciclib)
    1m
    Single arm, multicenter, exploratory phase II clinical study of new adjuvant therapy with Trastuzumab Deruxtecan for Injection for injection for early or locally advanced HR positive/HER2 low expression breast cancer with poor efficacy of dalpiciclib combined with endocrine therapy (ChiCTR2500110276)
    P4, N=30, Not yet recruiting, Anyang Tumor Hospital; Anyang Tumor Hospital
    New P4 trial
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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    ER positive • HER-2 expression • HER-2 underexpression
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    Enhertu (fam-trastuzumab deruxtecan-nxki) • letrozole • trastuzumab rezetecan (SHR-A1811) • AiRuiKang (dalpiciclib)
    1m
    Efficacy and safety of Dalpiciclib in combination with endocrine adjuvant therapy for middle/high-risk HR-positive early stage breast cancer: a multicenter, prospective clinical study (ChiCTR2500107587)
    P4, N=2000, Recruiting, Jilin Cancer Hospital; Jilin Cancer Hospital
    New P4 trial
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 amplification • HER-2 negative • HR positive + HER-2 negative
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    AiRuiKang (dalpiciclib)
    2ms
    Efficacy, Safety, and Biomarkers of Neoadjuvant Dalpiciclib (CDK4/6 inhibitor) plus Aromatase Inhibitors in Operable HER2-Negative Luminal B Breast Cancer: A Prospective, Single-Center, Single-Arm, Phase II Trial (DANCER). (PubMed, MedComm (2020))
    A novel baseline response index combining CCL4 and pRb showed excellent predictive performance and stratified patients by likelihood of clinical benefit, with ctDNA dynamics further refining stratification. These findings support DAL-AI as a promising neoadjuvant option and highlight the value of biomarker-guided strategies for treatment optimization.
    P2 data • Journal
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    HER-2 (Human epidermal growth factor receptor 2) • CCL19 (C-C Motif Chemokine Ligand 19) • GSTM1 (Glutathione S-transferase mu 1)
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    HER-2 negative
    |
    MammaPrint
    |
    AiRuiKang (dalpiciclib)
    2ms
    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, Not yet recruiting, Risen (Suzhou) Pharma Tech Co., Ltd.
    New P3 trial
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    fulvestrant • AiRuiKang (dalpiciclib)
    2ms
    Pyrotinib Maleate Tablets in Combination With Dalpiciclib Isethionate Tablets and Standard Endocrine Therapy (clinicaltrials.gov)
    P1/2, N=33, Not yet recruiting, The First Affiliated Hospital of Xiamen University
    New P1/2 trial
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    Irene (pyrotinib) • AiRuiKang (dalpiciclib)
    3ms
    Efficacy and safety of neoadjuvant treatment of trastuzumab and pyrotinib plus dalpiciclib in HR-negative/HER2-positive breast cancer: an exploratory, open-label phase II study. (PubMed, Int J Surg)
    In patients with HR-HER2 + EBC, the neoadjuvant therapy with trastuzumab, pyrotinib and dalpiciclib has promising activity and manageable toxicity. Further investigation is needed.
    P2 data • Journal
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative • HR negative • HER-2 negative + HR negative • HR negative + HER-2 positive
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    Irene (pyrotinib) • AiRuiKang (dalpiciclib) • Hercessi (trastuzumab-strf)
    3ms
    Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study (clinicaltrials.gov)
    P2, N=288, Not yet recruiting, Fudan University
    New P2 trial
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    Herceptin (trastuzumab) • Irene (pyrotinib) • fulvestrant • letrozole • anastrozole • exemestane • trastuzumab rezetecan (SHR-A1811) • AiRuiKang (dalpiciclib) • goserelin acetate • leuprolide acetate for depot suspension
    3ms
    Dalpiciclib Plus fulvestrant and pyrotinib in HR+/HER2-low advanced breast cancer after progression on CDK4/6 Inhibition (DapPLE-HER): a bayesian optimal phase II study. (PubMed, Int J Surg)
    The combination of dalpiciclib, fulvestrant, and pyrotinib demonstrated modest efficacy with a manageable safety profile in HR +/HER2-low advanced BC patients who had progressed on prior CDK4/6 inhibitor therapy. This novel regimen demonstrated exploratory efficacy and a favorable safety profile, warranting further validation in future randomized controlled studies.
    P2 data • Journal
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
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    Irene (pyrotinib) • fulvestrant • AiRuiKang (dalpiciclib)