AiRuiKang (dalpiciclib)

Approved by the Ethics Committee of Peking Union Medical College Hospital (Approval number: K3629); registered at ClinicalTrials. gov (NCT05613270).

CDK4/6 inhibitors plus endocrine therapy significantly improved survival in hormone receptor-positive, HER2-negative advanced breast cancer. Benefits in progression-free survival and overall survival were consistent across major clinical subgroups. Although all agents improved progression-free survival, only ribociclib and abemaciclib showed statistically significant overall survival benefits, whereas palbociclib did not, and data for dalpiciclib remain immature. Further head-to-head comparisons and assessments of toxicity profiles, as well as patient-reported outcomes, are needed.

This study enrolled 341 patients with HR+/HER2- MBC who received first-line CDK4/6i-based therapy consisting of palbociclib (n = 138), abemaciclib (n = 119), or dalpiciclib (n = 84) in combination with either an AI or fulvestrant. In this real-world analysis, dalpiciclib was associated with superior PFS compared to palbociclib as first-line CDK4/6i-based therapy for HR+/HER2- MBC. ET partner did not significantly impact effectiveness, supporting tailored CDK4/6i selection based on patient and disease characteristics.

P2, N=46, Not yet recruiting, Nanfang Hospital, Southern Medical University

Entecavir antiviral therapy led to suppressed viral replication and improved liver function during follow-up. This case emphasizes the need for HBV screening and close monitoring of viral markers/liver function in asymptomatic HBV carriers receiving dalpiciclib, as early antiviral intervention prevents severe liver complications. It also highlights the importance of clinical pharmacist-led medication follow-up management for outpatients receiving targeted anticancer therapy to avoid oversight of comorbidities and associated prophylactic treatment.

Preclinical studies have demonstrated synergistic antitumor activity when CDK4/6 inhibitors are combined with trastuzumab, pertuzumab, or newer HER2-targeted agents across multiple HER2+ breast cancer models. In the metastatic setting, phase II trials including MonarcHER and PATRICIA II have shown encouraging efficacy signals, while the phase III PATINA trial demonstrated a clinically meaningful 15.2-month progression-free survival benefit with palbociclib plus anti-HER2 therapy and endocrine therapy...Despite these advances, key challenges remain including the identification of predictive biomarkers, optimal treatment sequencing, and the integration of emerging HER2-targeted agents such as trastuzumab deruxtecan. Novel CDK4/6 inhibitors including dalpiciclib and next-generation agents are expanding therapeutic options, while combination strategies incorporating CDK7 inhibition represent future therapeutic frontiers. The evolving landscape of HER2+/HR+ breast cancer treatment increasingly emphasizes precision medicine approaches that leverage cell cycle control mechanisms to overcome resistance and improve patient outcomes across all disease stages.

P3, N=912, Recruiting, Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting --> Recruiting | Initiation date: Dec 2026 --> Mar 2026

P2, N=60, Recruiting, Hebei Medical University Fourth Hospital

P2, N=100, Enrolling by invitation, Peking University | Not yet recruiting --> Enrolling by invitation

P3, N=258, Recruiting, Fujian Cancer Hospital

P3, N=2288, Not yet recruiting, Fudan University

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.