[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528832":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":38,"responsibleParty":57,"collaborators":11,"id":61,"slug":11,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":11,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":11,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Shengjing Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"adebrelimab plus stereotactic radiotherapy and chemotherapy","EXPERIMENTAL",null,[13],"Drug: adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)",{"label":15,"type":16,"description":11,"interventionNames":17},"adebrelimab plus nab-paclitaxel + carboplatin","ACTIVE_COMPARATOR",[18],"Drug: adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)","Adebrelimab plus radiotherapy phase: radiotherapy was started on the day of the second cycle of adebrelimab administration every other day for 3 fractions; Adebrelimab plus chemotherapy phase: starting within 3-5 weeks after completion of radiotherapy, every 3 weeks for 6 cycles.",[9],{"type":21,"name":26,"description":26,"armGroupLabels":27,"otherNames":11},"adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)",[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Caigang Liu, Dr.","CONTACT","18940254967","liucg@sj-hospital.org",{"name":35,"role":31,"phone":36,"phoneExt":11,"email":37},"Nan Niu, Dr.","18940256668","niunannancy@163.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Shengjing Hospital of China Medical University","RECRUITING","Shenyang","Liaoning","110022","China",{"type":47,"coordinates":48},"Point",[49,50],123.43278,41.79222,{"lat":50,"lon":49},[53],{"name":54,"role":31,"phone":55,"phoneExt":11,"email":56},"Nan Niu, Phd","+8618940256668","niun@sj-hospital.org",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Caigang Liu","Clinical Professor","100528832",false,"NCT06165900","Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC","A Multicenter, Randomized Trial of Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) Versus Adebrelimab Combined With TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of Triple-negative Breast Cancer","Inclusion Criteria:\n\n* Treatment-naïve breast cancer female patients aged ≥ 18 years and ≤ 75 years;\n* Histopathologically confirmed early or locally advanced triple-negative invasive breast cancer according to the latest ASCO\u002FCAP guidelines, meeting the following conditions: (1) pathological type is triple-negative, specifically: ER negative: IHC \\\u003C 1%, PR negative: IHC \\\u003C 1%, HER2 negative: IHC 0\u002F1 + or IHC2 + but ISH negative;\n* Clinical stage II-III invasive breast cancer with measurable lesions according to RECIST 1.1;\n* ECOG score 0-1;\n* Able to tolerate preoperative and postoperative adjuvant radiotherapy after assessment by a radiologist;\n* Appropriate level of organ function\n* Patients voluntarily participate in and sign the informed consent form, are expected to have good compliance and cooperate with the study according to the requirements of the protocol.\n\nExclusion Criteria:\n\n* Patients with metastatic breast cancer or bilateral breast cancer;\n* Patients with inflammatory breast cancer or occult breast cancer;\n* Patients received any anti-tumor therapy within 12 months before signing the informed consent form, including chemotherapy, targeted therapy, radiotherapy, endocrine therapy, immunotherapy, biological therapy or tumor embolization;\n* Patients previously received PD-1\u002FPD-L1 antibody, CTLA-4 antibody, or other treatments against PD-1\u002FPD-L1 inhibitors;\n* Female patients who are pregnant and lactating, female patients who are fertile and have a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial.\n* Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia, and the subject has a known history of psychotropic drug abuse, alcoholism ;\n* Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); positive hepatitis B surface antigen (HBsAg) test, or positive hepatitis B core antibody (HBcAb) test followed by positive HBV-DNA test (HBV-DNA test was performed only in patients with negative HBsAg test and positive HBcAb test); positive hepatitis C virus (HCV) antibody test followed by positive HCV-RNA test (HCV-RNA test was performed only in patients with positive HCV antibody test)\n* Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.","FEMALE","18 Years","75 Years",{"count":71,"type":72},136,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","This study was an open-label, multicenter, randomized study. It is planned to include 136 patients with stage II-III triple negative breast cancer. Eligible subjects will be randomized to receive either the experimental arm: adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) or the control arm: adebrelimab plus nab-paclitaxel + carboplatin.",[78,79,80],"Stereotactic Radiotherapy","Immunotherapy","Breast Cancer","2024-01-02",{"date":83,"type":84},"2024-01-03","ACTUAL",{"date":86,"type":84},"2023-09-26",{"date":88,"type":72},"2028-12-15",{"name":5,"class":6},1]