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Participants received tocilizumab on day 1, followed by cisplatin/docetaxel on day 2 every four weeks for six cycles using a traditional 3+3 design with sentinel patients. Safety/tolerability was the primary endpoint; efficacy and pathological complete response in breast and axilla were secondary endpoints. BRCA1/2 status was assessed by DNA sequencing. In 30 patients, overall pCR reached 62% with axillary pCR of 81%.",{"@graph":69,"@context":122},[70,84,105],{"@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/safety-and-preliminary-efficacy-of-adding-tocilizumab-to-cisplatindocetaxel-for-the-treatment-of-locally-advanced-triple-negative-breast-cancer-patients-prospective-phase-12-clinical-trial/362478/",{"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/safety-and-preliminary-efficacy-of-adding-tocilizumab-to-cisplatindocetaxel-for-the-treatment-of-locally-advanced-triple-negative-breast-cancer-patients-prospective-phase-12-clinical-trial/362478.png","ImageObject",300,407,{"name":92,"@type":93},"Connor ","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-30","2026-09-23",true,{"@type":102,"interactionType":103,"userInteractionCount":52},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What was the main objective of the phase 1/2 trial?","Question",{"text":112,"@type":113},"The primary objective was the safety run-in, focusing on tolerability and toxicity profiles.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How were patients treated during the study?",{"text":117,"@type":113},"Participants received tocilizumab on day 1, then cisplatin/docetaxel on day 2 every four weeks for six cycles, following a traditional 3+3 design.",{"name":119,"@type":110,"acceptedAnswer":120},"What efficacy results were reported for pathological complete response?",{"text":121,"@type":113},"Overall pathological complete response (RCB class 0) was 62%, and axillary pCR was achieved by 81% of treated patients.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},362478,1790181539,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":52,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":44,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":144},687207022233,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","[www. nature.com/scientificreports](www. nature.com/scientificreports)  \nOPEN  \nSafety and preliminary efficacy of adding tocilizumab to cisplatin/ docetaxel for the treatment of locally advanced triple-negative breast cancer patients: prospective phase 1/2 clinical trial  \nTaher Al-Tweigeri1􀀍, AsmaTulbah3, Syed Akhtar1, MeshariAlzahrani1, Saleh Najjar3, Tusnem El Hassan1, Noura N. Alraouji2, Kauser Suleman1, Adher AlSayed1 & Abdelilah Aboussekhra2􀀍  \nTriple-negative breast cancer (TNBC) remains a challenge for clinicians due to its aggressive behavior and scarcity of effective treatment. Interleukin 6 (IL-6) is well known to contribute to poor therapeutic gain, tumor relapse, and aggressive tumor growth. Here, we have explored targeting the IL-6 signaling pathway by tocilizumab (Actemra) as a new potential therapeutic approach for the treatment ofTNBC patients. The participants were treated uniformly with tocilizumab on day 1, followed by cisplatin/docetaxel on day 2 every 4 weeks for a total of six cycles according to a traditional 3 + 3 design using a sentinel patient in each cohort. The primary objective of the safety run-in was tolerability/toxicity profiles, while the secondary endpoints included efficacy and pathological complete response (pCR) in breast and axilla (ypT0/ypN0) . The status of the BRCA1 and BRCA2 genes was determined by DNA sequencing in all patients. Thirty (30) patients with (T2-T4, N0-3) stage (IIB-III) TNBC were included in this phase I/II trial. They hada median age of 42 years, 63% were premenopausal, and 67% had nodal involvement at baseline. The median tumor size was 45 mm (range 25–150 mm), stage IIIA/B 26% and stage IIIC 50% . Germline BRCA1/2 mutations represented 27% of the patients. All assessable patients (n = 28) underwent surgery after neoadjuvant therapy (tocilizumab plus chemotherapy) . The overall pCR (RCB class 0) was 62%, and pCR in the axilla was reached by 81% of the treated patients. Patients with tumors bearing mutated BRCA1/2 achieved a 100% pCR rate. The present clinical trial shows that tocilizumab-dependent inhibition of the IL-6 signaling in a sequential fashion with chemotherapy is safe and tolerable for neoadjuvant treatment of the intricate and hard-to-treat TNBC patients.  \nTrial registration: ISRCTN50182475 “Safety and effectiveness of tocilizumab followed by cisplatin/docetaxel in advanced triplenegative breast cancer”(retrospective registration 19/03/2025) . [https://doi.org/10.1186/ISRCTN50182475](https://doi.org/10.1186/ISRCTN50182475. SCTR 19)[. SCTR 19](https://doi.org/10.1186/ISRCTN50182475. SCTR 19),111,002 (Saudi Food and Drug Authority)“Singlearm Phase I/II study of the safety, tolerability and efficacy of the Tocilizumab followed by cisplatin/docetaxel in patients with triple negative locally advanced breast cancer”(registration date 12/03/2020) .  \nKeywords Tocilizumab, Triple-negative breast cancer, Interleukin-6, Clinical trial  \n1Department of Medical Oncology, Cancer Center of Excellence, King Faisal Specialist Hospital and Research Center, MBC \\# 64, PO BOX 3354, 11211 Riyadh, Kingdom of Saudi Arabia. 2Department of Research Laboratories, King Faisal Specialist Hospital and Research Center, MBC\\#03, PO BOX 3354, 11211 Riyadh, Kingdom of Saudi Arabia.  \n3Department of Pathology, King Faisal Specialist Hospital and Research Center, MBC\\#03, PO BOX 3354, 11211 Riyadh, Kingdom of Saudi Arabia. 􀀍 [email: ttwegieri@kfshrc.edu.sa](email: ttwegieri@kfshrc.edu.sa); [aboussekhra@kfshrc.edu.sa](aboussekhra@kfshrc.edu.sa)  \n[www. nature.com/scientificreports/](www. nature.com/scientificreports/)  \nAbbreviations  \nAEs ALTAST BCSBRCA1/2 DFSECOGER FISH GCP HER2  \nIHCIDC IL-6 IL-6RIRB MRIMTDNACT  \nNCI CTCAE  \nORROS pCR PR PETCTRCBRP2DSFDA sIL-6R  \nsTILs TILs TNBC MTDDLT RD  \nAdverse events  \nAlanine aminotransferase Aspartate aminotransferase Breast conserving surgery  \nBreast Cancer gene 1/2  \nDisease-free survival  \nEastern Cooperative Oncology Group Estrogen recepto","cbCaij4ASMhFo0Ij","https://ap.wps.com/l/cbCaij4ASMhFo0Ij","pdf",1756299,"English","# Background\n## Rationale for targeting IL-6 in TNBC\n# Study design and treatment schedule\n## Primary objective: safety run-in\n## Secondary endpoints: efficacy and pCR\n# Patient characteristics and biomarker assessment\n## BRCA1/2 sequencing\n# Efficacy outcomes\n## Overall pCR and axillary pCR\n# Safety and tolerability conclusions","[{\"question\":\"What was the main objective of the phase 1/2 trial?\",\"answer\":\"The primary objective was the safety run-in, focusing on tolerability and toxicity profiles.\"},{\"question\":\"How were patients treated during the study?\",\"answer\":\"Participants received tocilizumab on day 1, then cisplatin/docetaxel on day 2 every four weeks for six cycles, following a traditional 3+3 design.\"},{\"question\":\"What efficacy results were reported for pathological complete response?\",\"answer\":\"Overall pathological complete response (RCB class 0) was 62%, and axillary pCR was achieved by 81% of treated patients.\"}]","Safety and preliminary efficacy of adding tocilizumab to cisplatin/docetaxel for the treatment of locally advanced triple-negative breast cancer patients - prospective phase 1/2 clinical trial | PDF",1790147893,23]