[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628109":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":32,"locations":38,"responsibleParty":51,"collaborators":22,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":22,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":41,"whyStopped":22,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SBRT-Toripalimab-Chemo Rescue","EXPERIMENTAL","All enrolled participants receive the same regimen:\n\n1. Stereotactic Body Radiation Therapy (SBRT): started within 1 week after confirmation of chemotherapy resistance.\n2. Toripalimab (anti-PD-1 antibody): cycle 1 starts the day after SBRT ends.\n3. Chemotherapy switch: every 21 days for 4 cycles.",[13,14,15],"Radiation: SBRT","Drug: Toripalimab (anti-PD-1 antibody)","Drug: Chemotherapy switch",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"RADIATION","SBRT","24 Gy in 3 daily fractions (8 Gy each) to the breast primary tumor, started within 1 week after confirmation of chemotherapy resistance.",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"DRUG","Toripalimab (anti-PD-1 antibody)","240 mg intravenous infusion every 21 days for 4 cycles",[9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"Chemotherapy switch","Albumin-bound paclitaxel 125 mg\u002Fm² (days 1 \\& 8) plus carboplatin AUC 6 (day 1)",[9],[33],{"name":34,"role":35,"phone":36,"phoneExt":22,"email":37},"Ting Zhang, phD.","CONTACT","+86-571-87783521","zezht@zju.edu.cn",[39],{"facility":40,"status":41,"city":42,"state":22,"zip":22,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":22},"The Department of Radiation Oncology，the Second Affiliated Hospital of Zhejiang University School of Medicine, hangzhou, zhejiang","RECRUITING","Hangzhou","China","CN",{"type":46,"coordinates":47},"Point",[48,49],120.16142,30.29365,{"lat":49,"lon":48},{"type":52,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100628109","phase-2-neoadjuvant-toripalimab-plus-sbrt-for-chemo-resistant-triple-negative-breast-cancer-100628109",false,"NCT07457359","Neoadjuvant Toripalimab Plus SBRT for Chemo-Resistant Triple-Negative Breast Cancer","Neoadjuvant Toripalimab Combined With Preoperative Radiotherapy for Initial Chemotherapy-Nonresponding Triple-Negative Breast Cancer Patients (NEOTRIO-2)","NEOTRIO-2","Inclusion Criteria:\n\n* Female, age 18-75 years, newly diagnosed invasive breast cancer.\n* Histologically confirmed triple-negative phenotype: ER \\\u003C 1 %, PR \\\u003C 1 % by IHC, HER2 negative (IHC 0\u002F1+ or IHC 2+ with ISH negative).\n* Clinical stage II-III (T2-4 or N1-3, M0).\n* Completed 2 cycles of standard neoadjuvant chemotherapy (taxane ± anthracycline ± platinum) and assessed as non-responder: stable disease (SD) or progressive disease (PD) by RECIST 1.1.\n* ECOG performance status 0 or 1.\n* Radiation oncologist confirms suitability for SBRT and subsequent standard post-operative radiotherapy.\n* Adequate organ function within 14 days before enrollment: WBC ≥ 2 000\u002FµL, ANC ≥ 1 500\u002FµL, platelets ≥ 100 000\u002FµL, Hb ≥ 9 g\u002FdL; Serum creatinine ≤ 2 mg\u002FdL or GFR ≥ 40 mL\u002Fmin; AST\u002FALT ≤ 2.5 × ULN, total bilirubin ≤ ULN (≤ 3 mg\u002FdL if Gilbert syndrome); INR ≤ 1.5 (on anticoagulation allowed if therapeutic range)\n* Negative HIV, HBV surface antigen, and HCV antibody (or HBV DNA \u002F HCV RNA negative if false-positive).\n\nExclusion Criteria:\n\n* Inflammatory breast cancer.\n* Any other malignancy requiring treatment within the past 3 years (except adequately treated basal-cell skin carcinoma or cervical CIS).\n* Active autoimmune disease, immunodeficiency, or systemic steroids \\> 10 mg\u002Fday prednisone equivalent within 2 years.\n* Clinically significant cardiovascular disease (unstable angina, NYHA III\u002FIV heart failure, recent MI).\n* Prior radiotherapy to the breast or chest wall.\n* Active infection requiring systemic therapy.\n* Known intolerance or hypersensitivity to toripalimab, paclitaxel, or carboplatin.\n* Pregnant or lactating women.","FEMALE","18 Years","75 Years",{"count":65,"type":66},18,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","The goal of this clinical trial is to test whether a \"rescue\" strategy can turn chemotherapy-resistant triple-negative breast cancer (TNBC) into a curable state. Patients whose tumors fail to shrink after 2 cycles of standard neoadjuvant chemotherapy will receive a short, high-precision course of stereotactic body radiotherapy (SBRT, 24 Gy in 3 daily fractions) to the breast primary tumor, followed by 4 cycles of toripalimab (an anti-PD-1 antibody) combined with albumin-bound paclitaxel plus carboplatin. The main questions are:\n\nCan this SBRT-immuno-chemo triplet raise the pathologic complete response (pCR; no invasive cancer in breast or nodes at surgery)? Can it produce an objective radiologic response (ORR) in at least half of the patients, allowing more breast-conserving operations and fewer mastectomies? Secondary objectives include safety, changes in tumor-infiltrating lymphocytes (TILs), event-free survival, and exploratory biomarkers (whole-exome and RNA-seq, PBMC immunoprofiling) to discover signatures of benefit. Participants will undergo image-guided core biopsies before and after SBRT, provide serial blood samples, and have definitive surgery 3-5 weeks after the last cycle.",[72],"TNBC, Triple Negative Breast Cancer",[74,75],"chemo-resistance","neoadjuvant SBRT","2026-03-04",{"date":78,"type":79},"2026-03-09","ACTUAL",{"date":81,"type":79},"2026-01-04",{"date":83,"type":66},"2029-01-04",{"name":5,"class":6},1]