2025年中国乳腺癌重要临床试验成果及展望OA

With the rising incidence of breast cancer and the continuous improvement of screening strategies,the rate of early diagnosis has increased substantially,leading to prolonged overall survival.High-quality clinical trials constitute the cornerstone of updates to clinical guidelines and expert consensus and continue to drive the optimization of breast cancer management.In recent years,breast cancer clinical trials conducted in China have shown steady advances in study design,sample size,and the development of innovative agents,gradually establishing a comprehensive evidence base that spans the entire disease course.Based on Chinese breast cancer clinical trials published between 2024 and 2025 in international journals and reported at major academic conferences,this review systematically summarizes representative studies with significant implications for current clinical practice.The scope includes endocrine therapy,chemotherapy,targeted therapy,immunotherapy,local therapy,molecular biomarkers,and the management of treatment-related adverse effects.In the field of endocrine therapy,multiple randomized phase Ⅲ trials have demonstrated the efficacy of domestically developed cyclin-dependent kinase 4/6(CDK4/6)inhibitors as adjuvant treatment in patients with high-risk hormone receptor(HR)-positive,human epidermal growth factor receptor 2(HER2)-negative early breast cancer,with sustained survival benefits also observed in the advanced disease setting,thereby establishing evidence across the disease continuum.Chemotherapy-related studies have focused on treatment de-escalation,with trials in HER2-positive and triple-negative breast cancer(TNBC)confirming the feasibility of anthracycline-or carboplatin-sparing strategies in both neoadjuvant and adjuvant settings,achieving reduced toxicity without compromising efficacy.In the field of targeted therapy,significant progress has been made with domestically developed anti-HER2 agents and antibody-drug conjugates(ADCs).Several prospective studies have explored chemotherapy-free or low-intensity chemotherapy regimens,demonstrating meaningful clinical activity in patients with HER2-positive and HER2-low advanced breast cancer.Regarding immunotherapy,the efficacy of domestically developed immune checkpoint inhibitors combined with chemotherapy has been confirmed in the neoadjuvant treatment of TNBC,while response-adapted and molecular subtype-guided immunotherapy strategies have provided new insights into individualized treatment approaches for HR-positive breast cancer.Advances in local therapy and molecular biomarker research have further supported de-escalation strategies in axillary management and optimization of adjuvant treatment decision-making.In addition,an increasing number of studies focusing on the management of treatment-related adverse effects reflect a paradigm shift in clinical research from a sole emphasis on survival outcomes toward greater attention to patients'quality of life.Through a systematic review of these recent advances,this article discusses their impact on contemporary breast cancer clinical practice and aims to provide a reference for further optimization of treatment strategies and the development of personalized therapy.