[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590245":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":47,"centralContacts":52,"locations":60,"responsibleParty":77,"collaborators":29,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":29,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":63,"whyStopped":29,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"HIFU\u002FToripalimab + nab-P\u002FToripalimab + EC","EXPERIMENTAL","Participants receive HIFU treatment, followed by toripalimab (Q3W) + nab-Paclitaxel (QW) for 4 cycles (12 weeks), followed by toripalimab (Q3W) + epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks). Each cycle lasts 21 days.",[13,14,15,16,17],"Procedure: HIFU","Drug: Toripalimab","Drug: nab-Paclitaxel (nab-P)","Drug: Epirubicin (E)","Drug: Cyclophosphamide (C)",{"label":19,"type":20,"description":21,"interventionNames":22},"nab-P\u002FEC","ACTIVE_COMPARATOR","Participants receive nab-Paclitaxel (QW) for 4 cycles (12 weeks), followed by epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks). Each cycle lasts 21 days.",[15,16,17],[24,30,35,39,43],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"PROCEDURE","HIFU","HIFU therapy is administered to the targeted breast lesion site.",[9],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"DRUG","Toripalimab","240 mg, IV infusion, Q3W",[9],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":29},"nab-Paclitaxel (nab-P)","125 mg\u002Fm2, IV infusion, QW",[9,19],{"type":31,"name":40,"description":41,"armGroupLabels":42,"otherNames":29},"Epirubicin (E)","90 mg\u002Fm2, IV infusion, Q3W",[9,19],{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":29},"Cyclophosphamide (C)","600 mg\u002Fm2, IV infusion, Q3W",[9,19],[48],{"name":49,"affiliation":50,"role":51},"Yiding Chen","2nd Affiliated Hospital, School of Medicine, Zhejiang University, China","PRINCIPAL_INVESTIGATOR",[53,57],{"name":49,"role":54,"phone":55,"phoneExt":29,"email":56},"CONTACT","+86 0571 87783759","ydchen@zju.edu.cn",{"name":58,"role":54,"phone":29,"phoneExt":29,"email":59},"Shijie Wu","shijiewu@zju.edu.cn",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"2nd Affiliated Hospital, School of Medicine, Zhejiang University","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":70,"coordinates":71},"Point",[72,73],120.16142,30.29365,{"lat":73,"lon":72},[76],{"name":49,"role":54,"phone":55,"phoneExt":29,"email":56},{"type":78,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100590245","phase-2-study-of-high-intensity-focused-ultrasound-hifu-combined-with-toripalimab-plus-chemotherapy-versus-chemotherapy-as-neoadjuvant-therapy-for-estrogen-receptor-positivehuman-epidermal-growth-factor-receptor-2-negative-erher2--breast-cancer-neohunter-100590245",false,"NCT06964906","Study of High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Therapy for Estrogen Receptor-Positive\u002FHuman Epidermal Growth Factor Receptor 2-Negative (ER+\u002FHER2-) Breast Cancer (NeoHunter)","A Randomized, Open-Label, Blinded Endpoint Study of High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Therapy for Estrogen Receptor-Positive\u002FHuman Epidermal Growth Factor Receptor 2-Negative (ER+\u002FHER2-) Breast Cancer (NeoHunter)","NeoHunter","Inclusion Criteria:\n\n1. Female patients aged 18-75 years.\n2. Invasive breast cancer without distant metastasis, including either T1c-T2 (≥ 2 cm), cN1-cN2, or T3-T4, cN0-cN2.\n3. Histopathologically confirmed ER-positive\u002FHER2-negative, PR \\\u003C 20% or Ki67 ≥ 20%, Grade 3 breast cancer.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\nExclusion Criteria:\n\n1. Female patients during pregnancy or lactation.\n2. Diagnosis of bilateral breast cancer, occult breast cancer, or distant metastasis confirmed by pathology.\n3. Has an active autoimmune disease that has received systemic treatment in the last 2 years.\n4. Has a known history of human immunodeficiency virus (HIV), hepatitis B, or known active hepatitis C virus infection.\n5. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.\n6. Has a known history of invasive malignancy that required systemic treatment in the last 5 years.\n7. Uncontrolled concomitant diseases include severe infection, liver disease, cardiovascular disease, kidney disease, respiratory disease, diabetes, and others requiring systemic treatment.","FEMALE","18 Years","75 Years",{"count":91,"type":92},140,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of high-intensity focused ultrasound (HIFU) combined with toripalimab plus chemotherapy versus chemotherapy as neoadjuvant therapy for ER+\u002FHER2- breast cancer.",[98],"ER+\u002FHER2- Breast Cancer",[100,101,102,32,103,104,105],"Breast Neoplasms","High-intensity focused ultrasound","PD1","nab-Paclitaxel","Epirubicin","Cyclophosphamide","2025-05-07",{"date":108,"type":109},"2025-05-11","ACTUAL",{"date":111,"type":109},"2025-03-04",{"date":113,"type":92},"2030-12-31",{"name":5,"class":6},1]