AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma 
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 0 Diseases   2 Trials   2 Trials   4 News 


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  • ||||||||||  AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma, Pegylated rhG-CSF (mecapegfilgrastim) / Jiangsu Hengrui Pharma
    Enrollment closed, Trial completion date, Trial primary completion date:  Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer (clinicaltrials.gov) -  May 14, 2025   
    P2,  N=132, Active, not recruiting, 
    Furthermore, RCB and pCR may not serve as optimal endpoints for evaluating the efficacy of CDK4/6i-based NET. Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Jan 2025
  • ||||||||||  AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma
    Biomarkers of neoadjuvant dalpiciclib in patients with operable HER2-negative luminal B breast cancer in the DANCER trial. (Hall A - Posters and Exhibits; Poster Bd #: 193) -  Apr 23, 2025 - Abstract #ASCO2025ASCO_779;    
    P2
    Dalpiciclib combined with cetuximab was well-tolerated and demonstrated potentially favorable efficacy in patients with anti-PD-1-resistant, HPV-negative R/M HNSCC. Patients with operable HER2-negative luminal B breast cancer who exhibit early ctDNA clearance, MammaPrint low-risk status, GSTM1 deletion, increased pRb/CDK4 expression, and higher plasma CCL4/CCL19 levels may derive substantial benefit from neoadjuvant dalpiciclib therapy.
  • ||||||||||  AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma, Irene (pyrotinib) / Jiangsu Hengrui Pharma, Herceptin (trastuzumab) / Roche
    New P4 trial:  To evaluate the efficacy of trastuzumab + pyrotinib + dalpiciclib  (EUDRACT) -  Apr 2, 2025   
    P4,  N=161, Not yet recruiting, 
  • ||||||||||  Review, Journal:  CDK4/6 as a Therapeutic Target in HR+/HER2- Breast Cancer Cells-Current Treatment Status. (Pubmed Central) -  Mar 28, 2025   
    Moreover, dalpiciclib is being investigated in HR+/HER2- BC treatment. This article will summarize clinical efficacy, recommendations, and differences in toxicity profile between palbociclib, ribociclib, and abemaciclib and will also discuss the possibility of using dalpiciclib in the treatment of breast cancer.
  • ||||||||||  AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma, HRS-1358 / Jiangsu Hengrui Pharma
    Trial primary completion date, Monotherapy:  A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer (clinicaltrials.gov) -  Mar 17, 2025   
    P1,  N=102, Recruiting, 
    https://www.crd.york.ac.uk/PROSPERO, identifier CRD42023490499. Trial primary completion date: Dec 2024 --> Jun 2025
  • ||||||||||  Retrospective data, Review, Journal:  Influence of ethnicity on cyclin-dependent kinase inhibitor efficacy and toxicity: A systematic review and meta-analysis. (Pubmed Central) -  Feb 13, 2025   
    The combination of CDK4/6i and ET significantly improves PFS and OS compared to ET alone in both Asian and non-Asian patients with HR+/HER2-aBC. Although the magnitude of benefit appears to be independent of ethnicity, future clinical trials should devise a standardized method for stratifying patients by ethnicity to more effectively assess potential differences in treatment benefits.
  • ||||||||||  Journal, Adverse events:  Adverse event profiles of CDK4/6 inhibitors: data mining and disproportionality analysis of the FDA adverse event reporting system. (Pubmed Central) -  Oct 8, 2024   
    Notably, our analysis found novel safety signals linked to CDK4/6 inhibitors, including nail-related disorders such as onychoclasis, nail disorder, and nail discoloration, and psychiatric concerns, including eating disorders and emotional disorder. Overall, the present study identified several new safety signals of CDK4/6 inhibitors, as well as differences among various drugs within the CDK4/6 category, through the use of the FDA FAERS, which deserve more careful monitoring in the clinic.
  • ||||||||||  Enrollment change:  BCTOP-L-M05: SNF Platform Study of HR+/ HER2-advanced Breast Cancer (clinicaltrials.gov) -  Oct 4, 2024   
    P2,  N=620, Recruiting, 
    Overall, the present study identified several new safety signals of CDK4/6 inhibitors, as well as differences among various drugs within the CDK4/6 category, through the use of the FDA FAERS, which deserve more careful monitoring in the clinic. N=140 --> 620
  • ||||||||||  AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma, HRS-1358 / Jiangsu Hengrui Pharma
    Enrollment status, Trial primary completion date, Monotherapy:  A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer (clinicaltrials.gov) -  Aug 7, 2024   
    P1,  N=102, Recruiting, 
    ClinicalTrials.gov identifier: NCT03481998. Enrolling by invitation --> Recruiting | Trial primary completion date: Jun 2024 --> Dec 2024