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Patients were randomized 1:1 to precision versus control treatment, with categorization into endocrine-based and targeted-based groups based on digital pathology classification. Among 251 randomized patients, precision treatment improved pathological complete response (pCR), mainly in the targeted-based group, while the endocrine-based group showed better tolerance. Toxicity remained manageable.",{"@graph":69,"@context":123},[70,84,106],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/precision-neoadjuvant-treatment-with-ai-assisted-subtyping-in-hrher2-breast-cancer-a-randomized-phase-2-trial-fascinate-n/357956/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/precision-neoadjuvant-treatment-with-ai-assisted-subtyping-in-hrher2-breast-cancer-a-randomized-phase-2-trial-fascinate-n/357956.png","ImageObject",300,407,{"name":92,"@type":93},"mieayamfan","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-03","2026-09-23",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",15,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"What design and patient groups were used in the FASCINATE-N phase 2 trial?","Question",{"text":113,"@type":114},"Stage II–III HR+/HER2− breast cancer patients were categorized into endocrine-based and targeted-based groups using SNF subtyping from digital pathology classification, then randomized 1:1 to precision or control treatment.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"What was the primary endpoint and what were the main efficacy results?",{"text":118,"@type":114},"The primary endpoint was pathological complete response (pCR). Precision treatment showed a significantly higher pCR rate overall, with the benefit mainly arising from the targeted-based group.",{"name":120,"@type":111,"acceptedAnswer":121},"How did the study address tolerability and toxicity?",{"text":122,"@type":114},"Toxicity was reported as manageable. Better tolerance was observed in the endocrine-based group receiving precision-guided therapy.","https://schema.org",{"og:url":83,"og:type":125,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":127,"canonical":83},"index,follow",{"doc_id":129,"site_id":62},357956,1790281809,{"code":4,"msg":5,"data":132},{"doc_id":129,"user_id":133,"nickname":92,"user_avatar":134,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":105,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145},962090893677,"https://ap-avatar.wpscdn.com/davatar_3d24733baf745e90a7e4bdd5f77d97b2","Article  \nPrecision neoadjuvant treatment with AI-assisted subtyping in HR+/HER2 − breast cancer: A randomized, phase 2 trial FASCINATE-N  \nAuthors  \nJun-Jie Li, Lin-Xiaoxi Ma, Peng Ji, ..., Zhong-Hua Wang, Ke-Da Yu,  \nZhi-Ming Shao  \nCorrespondence  \n[lijunjie_ronaldo@hotmail.com](lijunjie_ronaldo@hotmail.com) (J.-J.L.),  \n[yukeda@fudan.edu.cn](yukeda@fudan.edu.cn) (K.-D.Y.),  \n[zhimingshao@fudan.edu.cn](zhimingshao@fudan.edu.cn) (Z.-M.S.)  \nIn brief  \nLi et al. report findings from the FASCINATE-N trial showing that neoadjuvant precision treatment guided by SNF subtyping for patients with HR+/ HER2 − breast cancer exhibits potential clinical benefits, with improvement of efficacy in the targeted-based group and better tolerance in the endocrine-based group.  \n• Endocrine-CDK4/6i yields chemotherapy-like efficacy with superior tolerance  \n• Targeted-based precision therapy improves pCR with manageable toxicity  \n• Subtype-directed therapy optimizes outcome for early HR+/ HER2 − breast cancer  \nLi et al., 2026, Cell Reports Medicine 7, 102977  \nAugust 18, 2026 © 2026 The Author(s) . Published by Elsevier Inc.  \n[https://doi.org/10.1016/j.xcrm.2026.102977](https://doi.org/10.1016/j.xcrm.2026.102977)  \nll  \nll  \nOPEN ACCESS  \nArticle  \nPrecision neoadjuvant treatment with AI-assisted subtyping  \nin HR+/HER2 − breast cancer: A randomized, phase 2 trial FASCINATE-N  \nJun-Jie Li,1,2,3,* Lin-Xiaoxi Ma,1,2,3 Peng Ji,1,2,3 Li Chen,1,2,3 Jiong Wu,1,2 Guang-Yu Liu,1,2 Yi-Feng Hou,1,2 Gen-Hong Di,1,2 Zhen Hu,1,2 Yi-Zhou Jiang,1,2 Lei Fan,1,2 Zhong-Hua Wang,1,2 Ke-Da Yu,1,2,* and Zhi-Ming Shao1,2,4,*  \n1Department of Breast Surgery, Fudan University Shanghai Cancer Center, Key Laboratory of Breast Cancer in Shanghai, Shanghai 200032, China  \n2Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China  \n3These authors contributed equally  \n4Lead contact  \n*Correspondence: [lijunjie_ronaldo@hotmail.com](lijunjie_ronaldo@hotmail.com) (J.-J. L.), [yukeda@fudan.edu.cn](yukeda@fudan.edu.cn) (K.-D.Y.), [zhimingshao@fudan.edu.cn](zhimingshao@fudan.edu.cn) (Z.-M.S.) [https://doi.org/10.1016/j.xcrm.2026.102977](https://doi.org/10.1016/j.xcrm.2026.102977)  \nSUMMARY  \nIn this phase 2 trial (NCT05582499), patients with stage II–III hormone-receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2 − ) breast cancer were categorized into endocrine-based and targeted-based groups based on previously proposed similarity network fusion (SNF) subtyping by digital pathology classification and were then randomly assigned in a 1:1 ratio to receive precision or control treatment. The primary endpoint was pathological complete response (pCR) . Among 251 randomized patients, 49 were classified into an endocrine-based group and 202 into a targeted-based group. Patients receiving precision treatment had a significantly higher pCR rate (11.1%[90% confidence interval (CI), 6.8–16.8] vs. 4.0%[90% CI, 1.6–8.2]; p = 0.033), with the benefit mainly derived from the targeted-based group (13.9% in precision vs. 4.0% in control; p = 0.026) . Toxicity was manageable. Our findings highlight that guiding neoadjuvant precision treatment by SNF subtyping in patients with HR+/HER2 − breast cancer showed potential clinical benefits, with improvement of pCR in the targeted-based group and better tolerance in the endocrine-based group.  \nINTRODUCTION  \nBreast cancer is the most common malignant tumor for women worldwide, of which 70% are hormone-receptor-positive (HR+)/ human epidermal growth factor receptor 2-negative (HER2 − ) subtype.1 Despite advances in treatment for breast cancer, the cumulative risk of distant recurrence at 20 years remains around 40% in high-risk HR+/HER2 − early breast cancer.2 Neoadjuvant therapy may improve the operable rate and breast-conserving rate, and the current strategies for HR+/HER2 − disease include neoadjuvant chemotherapy (NCT), neoadjuvant endocrine therapy (NET), and NCT/NET combined with t","cbCaiontUJ3metAJ","https://ap.wps.com/l/cbCaiontUJ3metAJ","pdf",2926372,"English","# Summary\n# Introduction\n## Background and clinical need\n## SNF subtyping and prior validation","[{\"question\":\"What design and patient groups were used in the FASCINATE-N phase 2 trial?\",\"answer\":\"Stage II–III HR+/HER2− breast cancer patients were categorized into endocrine-based and targeted-based groups using SNF subtyping from digital pathology classification, then randomized 1:1 to precision or control treatment.\"},{\"question\":\"What was the primary endpoint and what were the main efficacy results?\",\"answer\":\"The primary endpoint was pathological complete response (pCR). Precision treatment showed a significantly higher pCR rate overall, with the benefit mainly arising from the targeted-based group.\"},{\"question\":\"How did the study address tolerability and toxicity?\",\"answer\":\"Toxicity was reported as manageable. Better tolerance was observed in the endocrine-based group receiving precision-guided therapy.\"}]","Precision neoadjuvant treatment with AI-assisted subtyping in HR+/HER2 - breast cancer - A randomized, phase 2 trial FASCINATE-N | PDF",1790132359,38]