- |||||||||| 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.
- |||||||||| 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
- |||||||||| AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma, Ibrance (palbociclib) / Pfizer, Verzenio (abemaciclib) / Eli Lilly
Enrollment closed, Trial completion date, Real-world evidence: Abemaciclib, Palbociclib or Dalpiciclib Combined with Endocrine Therapy As First-line Treatment in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - Dec 20, 2024 P=N/A, N=200, Active, not recruiting, Trial primary completion date: Sep 2024 --> Dec 2024 Recruiting --> Active, not recruiting | Trial completion date: Nov 2024 --> Feb 2025
- |||||||||| AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma, Ibrance (palbociclib) / Pfizer, Verzenio (abemaciclib) / Eli Lilly
Clinical, Journal, Real-world evidence, Real-world, Metastases: Real-world comparison of palbociclib, abemaciclib, and dalpiciclib as first-line treatments for Chinese HR+/HER2-metastatic breast cancer patients: a multicenter study (YOUNGBC-28). (Pubmed Central) - Dec 19, 2024 P Palbociclib, abemaciclib, and dalpiciclib demonstrated comparable efficacy in Chinese patients with advanced HR+/HER2- MBC. ClinicalTrials.gov identifier: NCT06344780.
- |||||||||| Journal: Comparative efficacy & safety of buparlisib plus fulvestrant, fulvestrant plus dalpiciclib, and ribociclib plus letrozole for postmenopausal, hormone receptor-positive, and HER2-negative breast cancer. (Pubmed Central) - Nov 18, 2024
Dalpiciclib plus fulvestrant is effective and comparatively safe in postmenopausal women with hormone receptor-positive and HER2-negative breast cancers. Dalpiciclib, buparlisib, fulvestrant, and ribociclib cause neutropenia, severe depression, adverse gastroenterological effects, and adverse hepatological effects, respectively.
- |||||||||| 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
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