[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603473":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":49,"collaborators":25,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":25,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":25,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":75,"whyStopped":25,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Henan Cancer Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TQB2102 group","EXPERIMENTAL","TQB2102 is administered intravenously at 6 mg\u002Fkg every 3 weeks for 6 cycles.",[13],"Drug: TQB2102",{"label":15,"type":16,"description":17,"interventionNames":18},"TCbHP","ACTIVE_COMPARATOR","Docetaxel + carboplatin + trastuzumab + pertuzumab (every 3 weeks)",[19],"Drug: Docetaxel + Carboplatin + Trastuzumab +Pertuzumab",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","TQB2102",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Docetaxel + Carboplatin + Trastuzumab +Pertuzumab","Docetaxel 75 mg\u002Fm2(day 1) , Carboplatin (AUC=6) (day 1), Trastuzumab (8mg\u002Fkg first dose, 6mg\u002Fkg sequential) and Pertuzumab (840mg first dose, 420mg\u002Fkg sequential) are administered intravenously every 3 weeks for 6 cycles.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Zhenzhen Liu","CONTACT","13603862755","zlyyliuzhenzhen0800@zzu.edu.cn",[37],{"facility":38,"status":25,"city":39,"state":40,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":25},"Henan cancer hospital","Zhengzhou","Henan","China","CN",{"type":44,"coordinates":45},"Point",[46,47],113.64861,34.75778,{"lat":47,"lon":46},{"type":50,"investigatorFullName":32,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Professor","100603473","phase-2-efficacy-of-tqb2102-versus-tcbhp-in-neoadjuvant-therapy-for-her2-positive-early-breast-cancer-100603473",false,"NCT07136974","Efficacy of TQB2102 Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer.","Comparing the Efficacy of TQB2102 and TCbHP in Neoadjuvant Treatment for HER2-positive Early Breast Cancer: A Randomized Phase II Clinical Trial.","Inclusion Criteria:\n\n1. 18-70 years,\n2. ECOG performance status 0-1;\n3. Clinical T2-T4, or T1c with axillary lymph node metastasis; Confirmed HER2-positive status (per 2018 ASCO\u002FCAP HER2 Testing Guidelines, defined as IHC 3+ or FISH positive);\n4. Clinically measurable lesion: Lesion measurable by ultrasound, mammography, or optional MRI within 1 month before randomization;\n5. No chemotherapy contraindications based on organ and bone marrow function tests within 1 month prior to chemotherapy: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, Hemoglobin ≥90 g\u002FL, Platelet count ≥100×10⁹\u002FL, Total bilirubin \\\u003C1.5 × ULN (upper limit of normal), Creatinine \\\u003C1.5 × ULN, AST\u002FALT \\\u003C1.5 × ULN, Echocardiography: Left ventricular ejection fraction (LVEF) ≥50%;\n6. For women of childbearing potential: Negative serum pregnancy test within 14 days before randomization;\n7. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Stage IV (metastatic) breast cancer;\n2. Prior treatments received including chemotherapy, endocrine therapy, targeted therapy, or radiotherapy; History of other malignancies within 3 years or concurrent malignancies. Exceptions: Other malignancies treated with surgery alone achieving ≥5-year disease-free survival (DFS) . Cured cervical carcinoma in situ or non-melanoma skin cancer;\n3. Major non-breast cancer-related surgical procedures within 4 weeks prior to enrollment, or incomplete recovery from such procedures;\n4. Significant cardiac disease or conditions including but not limited to: History of heart failure or systolic dysfunction (LVEF \\\u003C50%). Uncontrolled high-risk arrhythmias: Atrial tachycardia, resting heart rate \\>100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or high-grade atrioventricular block (Mobitz II second-degree or third-degree AV block). Angina requiring anti-anginal medication. Clinically significant valvular heart disease. ECG evidence of transmural myocardial infarction. Poorly controlled hypertension (SBP \\>180 mmHg and\u002For DBP \\>100 mmHg);\n5. Contraindications to chemotherapy per investigator's assessment due to severe uncontrolled comorbidities;\n6. Known hypersensitivity to protocol drug components;\n7. History of immunodeficiency disorders (including HIV positivity), other acquired\u002Fcongenital immune deficiencies, or organ transplantation;\n8. Any concurrent condition that in the investigator's judgment would jeopardize patient safety or compromise study completion, or other grounds for ineligibility.","ALL","18 Years","70 Years",{"count":63,"type":64},280,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","The aim of this study is to evaluate the efficacy and safety of TQB2102 compared to TCbHP in the neoadjuvant treatment of HER2-positive breast cancer. Participants will randomly assigned, in a 1:1 ratio, to receive either TQB2102 or TCbHP for 6 cycles. Patients will undergo definitive surgery (breast conservation or mastectomy with sentinel lymph-node evaluation or axillary dissection) 3 to 6 weeks after the last cycle of the neoadjuvant phase. Primary endpoint is pathological complete response, defined as pathological stage ypT0\u002FTis ypN0 at the time of definitive surgery.",[70,71],"Breast Cancer","HER2 + Breast Cancer",[73,74],"HER2 positive","neoadjuvant therapy","NOT_YET_RECRUITING","2025-08-16",{"date":78,"type":79},"2025-08-22","ACTUAL",{"date":81,"type":64},"2025-09-01",{"date":83,"type":64},"2030-08-30",{"name":5,"class":6},1]