[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567674":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":36,"locations":46,"responsibleParty":63,"collaborators":30,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":30,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":30,"overallStatus":49,"whyStopped":30,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"The control group","ACTIVE_COMPARATOR","Patients in this arm receive only a single injection of toripalimab without any radiotherapy as an initial treatment. After a three-week interval, patients receive the standard neoadjuvant chemotherapy in combination with toripalimab, starting with four cycles of paclitaxel and toripalimab, followed by four cycles of epirubicin and toripalimab.",[13],"Drug: Immuno-chemotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"The SBRT-combined group 1","EXPERIMENTAL","Patients enrolled in this treatment arm will undergo SBRT focused on the primary tumor, receiving a total dose of 24Gy divided into three fractions over the course of 3 to 5 working days. Following the radiation therapy, toripalimab will be administered between the second and fifth days post-treatment. After a three-week rest period, patients will commence the standard neoadjuvant chemotherapy regimen combined with toripalimab. This regimen will begin with four cycles of paclitaxel combined with toripalimab and followed by four cycles of epirubicin combined with toripalimab.",[19,13],"Radiation: SBRT",{"label":21,"type":16,"description":22,"interventionNames":23},"The SBRT-combined group 2","In this treatment protocol, patients will receive a total radiation dose of 24Gy in three fractions, specifically targeting the primary tumor. Concurrently, the axillary lymph nodes will be treated with a dose of 9Gy in three fractions. This radiation therapy will be conducted over a period of 3 to 5 working days. Following the radiation therapy, toripalimab will be administered between the second and fifth days after the completion of the radiation treatment. After a three-week interval, patients will proceed with the standard neoadjuvant chemotherapy regimen combined with toripalimab. This regimen includes an initial phase of four cycles of paclitaxel paired with toripalimab, which will be followed by a subsequent phase of four cycles of epirubicin paired with toripalimab.",[19,13],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"RADIATION","SBRT","Target the primary tumor region with a single dose of 8Gy, or deliver a dose of 3Gy to the axillary lymph nodes, administered once a day for three consecutive days.",[15,21],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"DRUG","Immuno-chemotherapy","Standard new adjuvant treatment with toripalimab combined with chemotherapy, that is in the first phase consisting of paclitaxel and toripalimab for four cycles, followed by epirubicin, cyclophosphamide, and toripalimab for another four cycles.",[15,21,9],[37,42],{"name":38,"role":39,"phone":40,"phoneExt":30,"email":41},"Jian Huang","CONTACT","+86-13958123068","drhuangjian@zju.edu.cn",{"name":43,"role":39,"phone":44,"phoneExt":30,"email":45},"Ting Zhang","+86-571-87783521","zezht@zju.edu.cn",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":30,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"2nd Affiliated Hospital, School of Medicine, Zhejiang University","RECRUITING","Hangzhou","Zhejiang","China","CN",{"type":55,"coordinates":56},"Point",[57,58],120.16142,30.29365,{"lat":58,"lon":57},[61],{"name":62,"role":39,"phone":44,"phoneExt":30,"email":45},"Ting Zhang, phD",{"type":64,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100567674","phase-2-neoadjuvant-toripalimab-and-radiotherapy-treatment-in-n-hr-breast-cancer-100567674",false,"NCT06671262","Neoadjuvant Toripalimab and Radiotherapy Treatment in N+ HR+ Breast Cancer","Neoadjuvant Toripalimab and Radiotherapy Treatment in Lymph Nodes Positive HR Positve Breast Cancer（NEOTRIO-HR）","NEOTRIO-HR","Inclusion Criteria:\n\n* High-risk HR+\u002FHER2-negative breast cancer is defined as ER≥1%, HER2-negative (\\\u003C2+ Her2 IHC or \\\u003C2.2 HER2\u002FCEP17 ratio by FISH) and either histologic grade II-III or a high-risk genomic assay score (Oncotype RS\\>25, high risk Mammaprint, PAM-50, EndoPredict or ProSigna score). primary tumor size ≥1.0 cm in maximum diameter and axillary node-positive breast cancer;\n* Stage T1-4N+M0 (i.e., Stage II, III), with confirmed N+ by biopsy, and no signs of distant metastasis;\n* The initial PD-L1 expression level conducted on the tumor tissue sample with Combined Positive Score (CPS) or Tumor Proportion Score (TPS)\\\u003C 10%;\n* ECOG score of 0-1;\n* Screening laboratory values must meet the following criteria: i. White blood cells (WBCs) ≥ 2000\u002FμL ii. Absolute neutrophil count (ANC) ≥ 1500\u002FμL iii. Platelets ≥ 100 x 103\u002FμL iv. Hemoglobin ≥ 11.0 g\u002FdL v. Serum creatinine ≤ 2 mg\u002FdL (or glomerular filtration rate ≥ 40 ml\u002Fmin) vi. AST ≤ 2.5 x upper limit of normal (ULN) vii. ALT ≤ 2.5 x ULN viii. Total bilirubin within normal limits (except subjects with Gilbert's syndrome, who must have total bilirubin \\\u003C 3.0 mg\u002FdL) ix. INR ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulant(s) x. Negative HIV screening test xi. Negative screening tests for Hepatitis B and Hepatitis C. Patients with positive results that do not indicate true active or chronic infection may enroll after discussion and consensus agreement by the treating physician and principal investigator.\n\nExclusion Criteria:\n\n* Inflammatory breast cancer\n* Life-threatening organ dysfunction or complications, active infectious diseases, active hepatitis B, hepatitis C virus infection, autoimmune diseases within two years, undergoing immunosuppressive drug treatment or chronic systemic corticosteroid therapy (dose exceeding 10mg per day of prednisone or equivalent);\n* Clinically symptomatic heart disease;\n* Previous systemic treatment or radiotherapy for breast cancer;\n* Patients with cosmetic breast implants, i.e., having implants under the skin at the time of diagnosis;\n* Radiotherapy contraindications: history of radiotherapy;\n* Women shall not be breastfeeding.","FEMALE","18 Years","85 Years",{"count":77,"type":78},74,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","The goal of this clinical trial is to compare the efficacy and safety in patients with lymph node-positive HR+\u002FHER2- breast cancer. The main questions it aims to answer are:\n\n* Can the incorporation of intensified radiation to the tumor (tumor boost) enhance the pCR rate on the basis of neoadjuvant immuno-chemotherapy？\n* Can it improve the level of residual cancer burden (RCB) and change the tumor immune microenvironment? and How safe will be the combined therapy?\n\nParticipants will be randomly assigned to one of three treatment regimens:\n\n1. Preoperative toripalimab combined with SBRT targeting both the primary tumor and axillary lymph nodes, followed by chemotherapy;\n2. Preoperative toripalimab combined with SBRT focused solely on the primary tumor, followed by chemotherapy;\n3. Preoperative toripalimab combined with chemotherapy alone.\n\nFollowing the completion of their respective treatment regimens, participants will proceed to undergo surgery. The effectiveness of the treatments will be assessed through pathological evaluations, as well as by measuring levels of residual cancer burden (RCB) and examining changes in the tumor immune microenvironment.\n\nThe study aims to evaluate the safety of these combined treatment approaches and to determine if they offer superior efficacy compared to outcomes reported in previous studies.",[84],"Breast Adenocarcinoma","2025-02-09",{"date":87,"type":88},"2025-02-11","ACTUAL",{"date":90,"type":88},"2024-12-26",{"date":92,"type":78},"2027-11-01",{"name":5,"class":6},1]