[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552249":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":31,"centralContacts":44,"locations":31,"responsibleParty":50,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":31,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":31,"enrollmentInfo":67,"targetDuration":31,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":82,"whyStopped":31,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":31},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HIFU+Adebrelimab+Chemotherapy","EXPERIMENTAL","Induction phase: HIFU+Adebrelimab Neoadjuvant Therapy phase: Adebrelimab+ EC-T(Epirubicin + Cyclophosphamide → Docetaxel",[13,14,15,16,17],"Drug: Adebrelimab","Procedure: High Intensity Focused Ultrasoun（HIFU）","Drug: Cyclophosphamide","Drug: Epirubicin","Drug: Docetaxel",[19,26,32,36,40],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Adebrelimab","Adebrelimab 1200mg iv q3w",[9],[25],"PD-Li",{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","High Intensity Focused Ultrasoun（HIFU）","HIFU treatment at lesion site",[9],null,{"type":20,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Cyclophosphamide","600mg\u002Fm2 iv q3w",[9],{"type":20,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Epirubicin","90mg\u002Fm2 iv q3w",[9],{"type":20,"name":41,"description":42,"armGroupLabels":43,"otherNames":31},"Docetaxel","75mg\u002Fm2 iv q3w",[9],[45],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},"Wenbin Zhou, Professor","CONTACT","025-68308162","Zhouwenbin@njmu.edu.cn",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Wenbin Zhou","Professor",[55],{"name":56,"class":57},"Jiangsu Hengrui Pharmaceutical Co., Ltd.","INDUSTRY","100552249","phase-2-to-evaluate-the-efficacy-of-adebrelimab-combined-with-chemotherapy-after-hifu-induction-neoadjuvant-therapy-hrher2--breast-cancer-100552249",false,"NCT06470633","To Evaluate the Efficacy of Adebrelimab Combined With Chemotherapy After HIFU Induction Neoadjuvant Therapy HR+\u002FHER2- Breast Cancer","To Evaluate the Efficacy and Safety of Adebrelimab Combined With Chemotherapy Neoadjuvant Therapy in Early or Local Advanced Breast Cancer After Induction Treatment of High-intensity Focused Ultrasound and Adebrelimab","Inclusion Criteria:\n\n1. Female patients aged ≥ 18 years who require a negative pregnancy test for premenopausal and perimenopausal patients and promise to take reliable contraceptive measures during treatment;\n2. Histopathologically confirmed breast cancer patients who with hormone receptor- positive, which defined as estrogen receptor (ER) ≥ 1%, and\u002F or progesterone receptor (PR) ≥ 1%, and HER-2 (0 or +), or ++,but FISH is no amplification;\n3. Tumor size ≥ 3cm, and histological grade is 3 (poorly differentiated);\n4. Regardless of lymph node status, but without distant metastasis;\n5. According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, they have at least one evaluable target lesion;\n6. ECOG PS score: 0 - 1;\n7. New York Heart Association (NYHA) functional class I;\n8. Electrocardiogram without myocardial ischemia, echocardiography LVEF \\> 55%, cardiac markers: cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) test values within the normal range;\n9. Normal major organ function, Meet the following criteria:\n\nWBC ≥ 4.0 × 10 9\u002FL,Neutrophil count (ANC) ≥ 1.5 × 10 9\u002FL; platelet ≥ 100 × 10 9\u002FL; hemoglobin ≥ 10 g\u002FdL; serum creatinine ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) ≤ 2.5 × ULN; alanine aminotransferase (ALT) ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN; 9.The subject is able to understand the study procedures, voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with the follow-up.\n\nExclusion Criteria:\n\n1. Patients during pregnancy and lactation, women of childbearing age who refuse to take effective contraceptive measures during the study period; Patients with peripheral nervous system disorders caused by diseases or those with a history of significant mental disorders and central nervous system disorders;\n2. Serious or uncontrolled infections that may affect the evaluation of study treatment or study results, including but not limited to: active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positive, lung infection, etc.;\n3. Known allergy to the active ingredients or other components of the study drug or surgical contraindications;\n4. In addition to cured basal cell carcinoma of the skin and cured cervical carcinoma in situ, other cancers are disease-free for less than 5 years;\n5. Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, active gastrointestinal ulcers and other need treatment;\n6. Need to receive other anti-tumor therapy (except ovarian function inhibitors) during neoadjuvant therapy as judged by the investigator;\n7. Patients who are participating in other clinical trials within one month;\n8. Patients with severe heart disease or discomfort, Expected intolerance to chemotherapy,Including, but not limited to: a. fatal arrhythmia or higher grade atrioventricular block (second-degree type 2 \\[Mobitz 2\\] atrioventricular block or third-degree atrioventricular block); b. unstable angina pectoris; c. clinically significant valvular heart disease; d. transmural myocardial infarction on electrocardiogram; e. uncontrolled hypertension;\n9. Any other conditions that in the opinion of the investigator would make the patient inappropriate for participation in this study.","FEMALE","18 Years",{"count":68,"type":69},29,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","To explore the efficacy and safety of adebrelimab combined with chemotherapy (epirubicin + cyclophosphamide →docetaxel) neoadjuvant therapy early HR+\u002FHER2- breast cancer with high risk factors after the induction treatment of HIFU and adebrelimab.",[75,76],"Breast Cancer","HR+\u002FHER2- Breast Cancer",[78,79,80,81],"HR+\u002FHER2- early breast cancer","HIFU","Immunotherapy","Neoadjuvant therapy","NOT_YET_RECRUITING","2024-06-18",{"date":85,"type":86},"2024-06-24","ACTUAL",{"date":88,"type":69},"2024-08-01",{"date":90,"type":69},"2026-12-31",{"name":5,"class":6}]