2025年改变早期乳腺癌临床实践的重要研究成果及进展

张琪; 修秉虬; 吴炅

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2025年改变早期乳腺癌临床实践的重要研究成果及进展

更新时间：2026-01-12

- 2025年改变早期乳腺癌临床实践的重要研究成果及进展
- Chin Oncol (2026)
- 作者机构：
  
  复旦大学附属肿瘤医院乳腺外科，复旦大学上海医学院肿瘤学系，上海 200032
- 作者简介：
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  CLC：
- Received：04 January 2026，
  
  Revised：2026-01-10，
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张琪, 修秉虬, 吴炅. 2025年改变早期乳腺癌临床实践的重要研究成果及进展[J/OL]. Chin Oncol, 2026.
DOI：

张琪, 修秉虬, 吴炅. 2025年改变早期乳腺癌临床实践的重要研究成果及进展[J/OL]. Chin Oncol, 2026. DOI：

摘要

随着肿瘤筛查策略的优化及公众健康意识的提升，早期乳腺癌的诊断比例不断提高。高质量临床研究作为诊疗指南与专家共识的重要循证基础，持续推动早期乳腺癌治疗模式的更新与完善。本文结合 2025 年国内外乳腺癌诊疗指南与共识的更新，系统梳理多项对早期乳腺癌临床实践产生重要影响的关键研究。在局部治疗方面，INSEMA 研究证实在临床淋巴结阴性、T1–T2 期患者中豁免外科腋窝分期具有非劣效性；COMET 研究在低风险导管原位癌患者中探索了主动监测的可行性；BRCA BCY Collaboration 研究提示，年轻BRCA胚系突变乳腺癌患者接受预防性切除手术可显著改善长期生存。IMPORT LOW、HYPART 及 NSABP B-51 等研究从不同风险人群层面支持了放疗范围与分割方案的个体化选择。在新辅助治疗方面，neoCARHP 及 CompassHER2-pCR 研究支持在 HER2 阳性早期乳腺癌中实施基于双靶治疗的降阶梯方案；DESTINY-Breast11 研究显示，德曲妥珠单抗（trastuzumab deruxtecan，T-DXd）联合双靶治疗可进一步提高高危患者的病理完全缓解率。三阴性乳腺癌领域，PLANeT 研究探索了低剂量帕博利珠单抗联合化疗的可行性。辅助治疗方面，APHINITY 和 KATHERINE 研究的长期随访结果进一步巩固了双靶治疗及恩美曲妥珠单抗（trastuzumab emtansine，T-DM1）在高风险 HER2 阳性患者中的治疗地位；DESTINY-Breast05 研究显示，T-DXd 在新辅助治疗后残留病灶患者中可显著改善无浸润性疾病生存。激素受体阳性乳腺癌中，EBCTCG Meta 分析及 monarchE、NATALEE 研究支持在高风险人群中实施内分泌治疗与 CDK4/6 抑制剂的强化策略，TAILORx 与 ASTER 70s 研究为不同年龄及遗传风险患者的化疗决策提供了精细化依据。在患者全程管理方面，POSITIVE 研究表明部分年轻激素受体阳性患者在严格监测下暂停内分泌治疗以实现妊娠是可行的；EUROPA 研究从健康相关生活质量角度比较了老年低风险患者单一放疗与内分泌治疗的差异，为治疗决策提供了新参考。总体而言，2025 年多项关键研究在局部治疗精准化、系统治疗升降阶及患者全程管理等方面取得重要进展，并已逐步转化为指南推荐，为早期乳腺癌个体化、精准化诊疗提供了坚实依据。

Abstract

With the optimization of tumor screening strategies and increasing public health awareness

the proportion of early breast cancer diagnoses has continued to rise. High-quality clinical studies provide the evidence base for clinical guidelines and expert consensus and drive continuous refinement of early breast cancer management. Based on updates of domestic and international breast cancer guidelines and consensuses in 2025

this article reviews key studies that have influenced clinical practice. In local treatment

the INSEMA study confirmed the non-inferiority of omitting surgical axillary staging in clinically node-negative T1–T2 patients; the COMET study explored active surveillance in low-risk ductal carcinoma in situ; and the BRCA BCY Collaboration study demonstrated improved long-term survival in young patients with germline BRCA mutations undergoing prophylactic surgery. IMPORT LOW

HYPART

and NSABP B-51 supported individualized radiotherapy fields and fractionation strategies. In the neoadjuvant setting

neoCARHP and CompassHER2-pCR supported de-escalated strategies based on dual HER2 blockade in HER2-positive early breast cancer

while DESTINY-Breast11 showed that trastuzumab deruxtecan (T-DXd) combined with dual blockade further improved pathological complete response in high-risk patients. In triple-negative breast cancer

the PLANeT study explored the feasibility of low-dose pembrolizumab combined with chemotherapy. In the adjuvant setting

long-term follow-up of APHINITY and KATHERINE reinforced the roles of dual HER2 blockade and trastuzumab emtansine (T-DM1) in high-risk HER2-positive disease

while DESTINY-Breast05 demonstrated improved invasive disease-free survival with T-DXd in patients with residual disease after neoadjuvant therapy. In hormone receptor–positive breast cancer

the EBCTCG meta-analysis and the monarchE and NATALEE studies supported intensified endocrine therapy combined with CDK4/6 inhibitors in high-risk populations

whereas TAILORx and ASTER 70s refined chemotherapy decision-making by age and genetic risk. Regarding comprehensive patient management

the POSITIVE study showed that temporary interruption of endocrine therapy to achieve pregnancy under strict monitoring was feasible in selected young patients

and the EUROPA study compared single-modality radiotherapy and endocrine therapy in older low-risk patients from a health-related quality-of-life perspective. Overall

key studies in 2025 advanced precision local treatment

risk-adapted systemic therapy

and comprehensive patient management

with evidence increasingly translated into guideline recommendations for individualized early breast cancer care.

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references

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Department of Breast Surgery, the First Affiliated Hospital of China Medical University

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Department of Breast Surgery, Fudan University Shanghai Cancer Center; Fudan University Breast Cancer Institute; Department of Oncology, Shanghai Medical College, Fudan University

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