乳腺癌的治疗方法在过去一个世纪中有了显著的改进，从以手术为主的方法到包括局部和全身治疗的协同治疗方法。早期疾病的全身治疗起初只是通过辅助试验与观察或安慰剂进行比较。随后的临床试验集中于治疗的微调，队列规模、持续时间和成本显著增加，这导致过去十年内对新辅助治疗模式的兴趣越来越高。新辅助试验设计具有评估治疗对肿瘤直径的直接影响并提供关于治疗前、中和后肿瘤生物学的比较分析独特的转化研究机会的优点。当前技术使预测更好的生物标志物的确定成为(新)辅助治疗的新时代。需要紧急加强制药工业和学术界之间的合作，共享数据，建立大型生物标志物数据库以及易于科学社区访问的患者结果。在这篇综述中，我们总结了从基因组前期到基因组后期的(新)辅助试验的发展，并提供了关键性见解，说明如何设计新辅助研究，讨论需要更好的终点以及更个性化的治疗策略，包括在新治疗设置中。©2022 Springer Nature Limited。

The treatment of breast cancer has improved dramatically over the past century, from a strictly surgical approach to a coordinated one, including local and systemic therapies. Systemic therapies for early-stage disease were initially tested against observation or placebo only in adjuvant trials. Subsequent clinical trials focusing on treatment 'fine-tuning' had a marked increase in cohort size, duration and costs, leading to a growing interest in the neoadjuvant setting in the past decade. Neoadjuvant trial designs have the advantages of enabling the direct evaluation of treatment effects on tumour diameter and offer unique translational research opportunities through the comparative analysis of tumour biology before, during and after treatment. Current technologies enabling the identification of better predictive biomarkers are shaping the new era of (neo)adjuvant trials. An urgent need exists to reinforce collaboration between the pharmaceutical industry and academia to share data and thus establish large databases of biomarker data coupled with patient outcomes that are easily accessible to the scientific community. In this Review, we summarize the evolution of (neo)adjuvant trials from the pre-genomic to the post-genomic era and provide critical insights into how neoadjuvant studies are currently designed, discussing the need for better end points and treatment strategies that are more personalized, including in the post-neoadjuvant setting.© 2022. Springer Nature Limited.