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Evidence summarized from pooled and prospective trials reports higher intracranial overall response rate (ORR) and improved median progression-free survival (mPFS) versus controls in both stable and active BMs, with durable responses observed across studies. Real-world ROSET-BM data further support overall survival and mPFS outcomes. The review also discusses clinical endpoint differences, including sample size, treatment lines, and LM inclusion.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/healthcare/","Healthcare",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/trastuzumab-deruxtecan-in-advanced-breast-cancer-patients-with-brain-metastases-or-leptomeningeal-metastases/409229/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/trastuzumab-deruxtecan-in-advanced-breast-cancer-patients-with-brain-metastases-or-leptomeningeal-metastases/409229.png","ImageObject",300,407,{"name":42,"@type":43},"Aria","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-11-03","2026-09-28",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",12,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"What intracranial outcomes does trastuzumab deruxtecan show in stable and active brain metastases?","Question",{"text":63,"@type":64},"Across pooled and prospective analyses, T-DXd yields superior intracranial ORR and improved median progression-free survival versus controls in both stable and active BMs.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"Which studies are cited to support durable intracranial activity of T-DXd?",{"text":68,"@type":64},"The document highlights DEBBRAH, TUXEDO-1, and DESTINY-Breast 12 as confirming durable intracranial activity in brain metastases.",{"name":70,"@type":61,"acceptedAnswer":71},"How do real-world ROSET-BM results compare, and what limitation is noted?",{"text":72,"@type":64},"ROSET-BM reports median overall survival of 27.0 months and mPFS of 14.6 months for active disease, while the text notes that prior trials enrolled relatively small numbers of patients with BM.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},409229,1790848678,{"code":4,"msg":82,"data":83},"success",[84,88,92,96,101,106,110,115,120,123,127],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},"Story & 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 \nCancer Pathogenesis and Therapy  \njournal [homepage:](homepage: www.journals.elsevier.com/cancer-pathogenesis-and-therapy)[ www.journals.elsevier.com/cancer-pathogenesis-and-therapy](homepage: www.journals.elsevier.com/cancer-pathogenesis-and-therapy)  \nIdea and Opinion  \nTrastuzumab deruxtecan in advanced breast cancer patients with brain metastases or leptomeningeal metastases  \nJinsong Liu a, b, 1, Liuliu Quan a, b, 1, Die Sang c, Xiao Guand, Min Dou e, Jian Yueb, Peng Yuan b, *  \na Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China  \nb Department of VIP Medical Services, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China  \nc Department of Internal Medicine, Sanhuan Cancer Hospital, Beijing 100021, China  \nd State Key Lab of Molecular Oncology and Department of Pancreatic and Gastric Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China  \ne Renhe Hospital, Shanghai University, Shanghai 201900, China  \n\n| H I G H L I G H T S |\n| --- |\n| 􀀁 Trastuzumab deruxtecan showed superior intracranial overall response rate (ORR) and median progression-free survival (mPFS) than controls in both stable and active brain metastases.\u003Cbr>􀀁 DEBBRAH, TUXEDO-1, and DESTINY-Breast 12 confirm durable intracranial activity in brain metastases with trastuzumab deruxtecan.\u003Cbr>􀀁 Real-world ROSET-BM data reported median overall survival (OS, 27.0 months) and mPFS (14.6 months) in active BM, reinforcing T-DXd efficacy.\u003Cbr>􀀁 In leptomeningeal metastases (LM) cohorts, T-DXd achieved clinical benefit rate (71.4–100%), mOS (10.4–13.3 months), and mPFS (8.9–17.5 months) across studies.\u003Cbr>􀀁 For active BM, local intervention plus T-DXd (or tucatinib combination) is recommended based on efficacy stratification. |\n\nA R T I C L E I N F O  \nManaging Editor: Peng Lyu  \nClinical studies on trastuzumab deruxtecan for human epidermal growth factor receptor 2-positive brain metastases  \nSeveral previous clinical studies have suggested significant intracranial activity of trastuzumab deruxtecan (T-DXd) in brain metastases (BMs) of human epidermal growth factor receptor 2-positive (HER2-positive) metastatic breast cancer (mBC). Pooled analyses from DESTINY-Breast (DB) 01, 02, and 03 showed that T-DXd outperformed controls in terms of intracranial overall response rate (ORR) and median progression-free survival (mPFS). Specifically, for patients with stable BM, the ORR was 45.2% with T-DXd vs. 27.6% with controls, and mPFS was 12.3 months vs. 8.7 months, respectively. In patients with active BM,  \nT-DXd demonstrated an ORR of 45.5% compared to 12.0% for controls, and an mPFS of 18.5 months vs. 4.0 months.1 Additionally, 35 patients with active BM were treated with T-DXd in the dose-expansion phase of the DB 07 study.2 The ORR, according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, was 80.0%, including four and 24 patients in complete and partial remission, respectively, with an mPFS and a 12-month progression-free survival (PFS) rate of 19.5 months and 80.0%, respectively. The findings of this study demonstrate that T-DXd has favorable effects in active BM. Furthermore, in the DEBBRAH trial, which comprised five clinical cohorts, analysis of the measurable lesion group exhibited an ORR of 66.7% for the overall population, with a 6- and 9-month PFS rate of 78.7% and 61.4%,  \n* Corresponding author. Department of VIP Medical Services, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese  \nAcademy of Medical Scienc","cbCaidJthkh7cIor","https://ap.wps.com/l/cbCaidJthkh7cIor","pdf",223606,"English","# Highlights\n## Intracranial efficacy in brain metastases and leptomeningeal metastases\n# Article Information\n## Prior clinical trials and pooled analyses (DESTINY-Breast)\n## DEBBRAH and TUXEDO-1 study findings\n## Real-world ROSET-BM outcomes\n## Interpretation of differences in endpoints","[{\"question\":\"What intracranial outcomes does trastuzumab deruxtecan show in stable and active brain metastases?\",\"answer\":\"Across pooled and prospective analyses, T-DXd yields superior intracranial ORR and improved median progression-free survival versus controls in both stable and active BMs.\"},{\"question\":\"Which studies are cited to support durable intracranial activity of T-DXd?\",\"answer\":\"The document highlights DEBBRAH, TUXEDO-1, and DESTINY-Breast 12 as confirming durable intracranial activity in brain metastases.\"},{\"question\":\"How do real-world ROSET-BM results compare, and what limitation is noted?\",\"answer\":\"ROSET-BM reports median overall survival of 27.0 months and mPFS of 14.6 months for active disease, while the text notes that prior trials enrolled relatively small numbers of patients with BM.\"}]","Trastuzumab deruxtecan in advanced breast cancer patients with brain metastases or leptomeningeal metastases | PDF",1790581717]