[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593179":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":389,"collaborators":25,"id":391,"slug":392,"hasResults":393,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":25,"eligibilityCriteria":397,"healthyVolunteers":393,"sex":398,"minAge":399,"maxAge":400,"enrollmentInfo":401,"targetDuration":25,"studyType":404,"phases":405,"briefSummary":407,"conditions":408,"keywords":25,"overallStatus":199,"whyStopped":25,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":420},{"fullName":5,"class":6},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TQB2102 for Injection","EXPERIMENTAL","Administer by intravenous infusion, with a 21-day treatment cycle.",[13],"Drug: TQB2102 for Injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Docetaxel combined + Trastuzumab +Pertuzumab","ACTIVE_COMPARATOR","Docetaxel: 75mg\u002Fm2, administered once every 3 weeks, intravenous infusion for 60 minutes, for a total of 6 cycles; Trastuzumab: The initial loading dose is 8mg\u002Fkg, and 6mg\u002Fkg is administered every 3 weeks thereafter; Pertuzumab: initial loading dose of 840mg, intravenous infusion for 60 minutes; Afterwards, administer 420mg every 3 weeks. After each infusion of pertuzumab, it is recommended to observe for 30-60 minutes. After the observation, trastuzumab or chemotherapy can be continued.",[19],"Drug: Docetaxel combined + Trastuzumab +Pertuzumab",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","TQB2102 is a next-generation HER2 Antibody-Drug Conjugate drug proposed for patients with HER2 positive Recurrent\u002FMetastatic Breast Cancer.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Positive control.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Zhimin Shao, Doctor","CONTACT","18017312288","szm@163.com",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Yongmei Yin, Doctor","13951842727","ym.yin@hotmail.com",[40,59,70,85,100,109,124,139,154,168,182,197,213,225,240,255,264,278,293,308,320,335,349,364,374],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Anhui Provincial Cancer 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University","Kaifeng","Henan","475099",{"type":49,"coordinates":145},[146,147],114.30742,34.7986,{"lat":147,"lon":146},[150],{"name":151,"role":32,"phone":152,"phoneExt":25,"email":153},"Hong Lu, Doctor","138337850019","hhyyluhong@126.com",{"facility":155,"status":42,"city":156,"state":142,"zip":157,"country":46,"countryCode":47,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Puyang Oilfield General Hospital","Puyang","457001",{"type":49,"coordinates":159},[160,161],115.04363,35.75641,{"lat":161,"lon":160},[164],{"name":165,"role":32,"phone":166,"phoneExt":25,"email":167},"Wenbin Yue, Doctor","13839276125","yuewenbin2013@163.com",{"facility":169,"status":42,"city":170,"state":142,"zip":171,"country":46,"countryCode":47,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"The Third People's Hospital of Zhengzhou","Zhengzhou","450000",{"type":49,"coordinates":173},[174,175],113.64861,34.75778,{"lat":175,"lon":174},[178],{"name":179,"role":32,"phone":180,"phoneExt":25,"email":181},"Lige Yao, Master","13693718212","577663634@qq.com",{"facility":183,"status":42,"city":184,"state":185,"zip":186,"country":46,"countryCode":47,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Zhongnan Hospital of Wuhan University","Wuhan","Hubei","434000",{"type":49,"coordinates":188},[189,190],114.26667,30.58333,{"lat":190,"lon":189},[193],{"name":194,"role":32,"phone":195,"phoneExt":25,"email":196},"HaiJun Yu, Doctor","13971665181","doctoryhj@126.com",{"facility":198,"status":199,"city":200,"state":201,"zip":202,"country":46,"countryCode":47,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Hunan Cancer 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Hospital","Shenyang","110000",{"type":49,"coordinates":269},[270,271],123.43278,41.79222,{"lat":271,"lon":270},[274],{"name":275,"role":32,"phone":276,"phoneExt":25,"email":277},"Tao Sun, Doctor","13940404526","lnzlrxnsy@163.com",{"facility":279,"status":42,"city":280,"state":281,"zip":282,"country":46,"countryCode":47,"cosmosGeoPoint":283,"geoPoint":287,"contacts":288},"The First Affiliated Hospital of Xi'An Jiaoting Yniversity","Xi'an","Shaanxi","710000",{"type":49,"coordinates":284},[285,286],108.92861,34.25833,{"lat":286,"lon":285},[289],{"name":290,"role":32,"phone":291,"phoneExt":25,"email":292},"Jin Yang, Doctor","18991232383","Yj_Clinicalstudy@163.com",{"facility":294,"status":42,"city":295,"state":296,"zip":297,"country":46,"countryCode":47,"cosmosGeoPoint":298,"geoPoint":302,"contacts":303},"Cancer Hospital of Shandong First Medical University","Jinan","Shandong","250117",{"type":49,"coordinates":299},[300,301],116.99722,36.66833,{"lat":301,"lon":300},[304],{"name":305,"role":32,"phone":306,"phoneExt":25,"email":307},"Huihui Li, Doctor","15553103209","15553103209@163.com",{"facility":309,"status":42,"city":310,"state":311,"zip":312,"country":46,"countryCode":47,"cosmosGeoPoint":313,"geoPoint":317,"contacts":318},"Fudan University shanghai cancer center","Shanghai","Shanghai Municipality","201321",{"type":49,"coordinates":314},[315,316],121.45806,31.22222,{"lat":316,"lon":315},[319],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"facility":321,"status":42,"city":322,"state":323,"zip":324,"country":46,"countryCode":47,"cosmosGeoPoint":325,"geoPoint":329,"contacts":330},"Shanxi Cancer Hospital","Taiyuan","Shanxi","030000",{"type":49,"coordinates":326},[327,328],112.56028,37.86944,{"lat":328,"lon":327},[331],{"name":332,"role":32,"phone":333,"phoneExt":25,"email":334},"Guohui Han, Master","13754858188","13754858188@163.com",{"facility":336,"status":42,"city":337,"state":323,"zip":338,"country":46,"countryCode":47,"cosmosGeoPoint":339,"geoPoint":343,"contacts":344},"Yuncheng Central Hospital, Shanxi Province","Yuncheng","044099",{"type":49,"coordinates":340},[341,342],110.99278,35.02306,{"lat":342,"lon":341},[345],{"name":346,"role":32,"phone":347,"phoneExt":25,"email":348},"Xiaoke Hou, Master","17703591026","hxk13720980018@163.com",{"facility":350,"status":42,"city":351,"state":352,"zip":353,"country":46,"countryCode":47,"cosmosGeoPoint":354,"geoPoint":358,"contacts":359},"Tianjin Cancer Hospital Airport Hospital","Tianjin","Tianjin Municipality","300060",{"type":49,"coordinates":355},[356,357],117.17667,39.14222,{"lat":357,"lon":356},[360],{"name":361,"role":32,"phone":362,"phoneExt":25,"email":363},"Chunfang Hao, Doctor","13602031629","haochf@163.com",{"facility":365,"status":42,"city":351,"state":352,"zip":353,"country":46,"countryCode":47,"cosmosGeoPoint":366,"geoPoint":368,"contacts":369},"Tianjin Medical University Cancer Institute & Hospital",{"type":49,"coordinates":367},[356,357],{"lat":357,"lon":356},[370],{"name":371,"role":32,"phone":372,"phoneExt":25,"email":373},"Yehui Shi, Doctor","18622221183","shiyehui@tjmuch.com",{"facility":375,"status":42,"city":376,"state":377,"zip":378,"country":46,"countryCode":47,"cosmosGeoPoint":379,"geoPoint":383,"contacts":384},"The Affiliated Tumor Hospital of Xinjiang Medical University","Ürümqi","Xinjiang","831399",{"type":49,"coordinates":380},[381,382],87.60046,43.80096,{"lat":382,"lon":381},[385],{"name":386,"role":32,"phone":387,"phoneExt":25,"email":388},"Bing Zhao, Doctor","13899908184","819502412@qq.com",{"type":390,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100593179","phase-3-a-clinical-study-of-tqb2102-versus-docetaxel-plus-trastuzumab-and-pertuzumab-in-the-treatment-of-her2-positive-recurrent-or-metastatic-breast-cancer-100593179",false,"NCT07003074","A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer","A Randomized, Open, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) Positive Recurrent or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Subjects voluntarily enrolled in this study with good compliance\n* Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1\n* HER2 positive, recurrent or metastatic invasive breast cancer confirmed by histopathology or cell pathology\n* Defined hormone receptor (HR) status\n* Has not received systemic anti-tumor therapy during the recurrence\u002Fmetastasis stage (acceptable ≤ first-line endocrine therapy)\n* If receiving (new) adjuvant therapy, it is required that the time interval between the end of systemic therapy (excluding endocrine therapy) and the discovery of recurrence\u002Fmetastasis be greater than 12 months\n* Have at least one measurable lesion according to RECIST 1.1 criteria;\n* Good major organ function\n\nExclusion Criteria:\n\n* It is known that there is spinal cord compression or active central nervous system metastasis;\n* Subjects with only skin and\u002For brain lesions as target lesions\n* Combined diseases and medical history\n\n  1. Have had or currently have other malignant tumors within the past 5 years of randomization\n  2. Unrelieved toxic reactions above Common Terminology Criteria (CTC) AE grade 1 caused by any previous treatment\n  3. Received major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to randomization\n  4. There are diseases that affect intravenous injection and venous blood collection\n  5. There are congenital bleeding and coagulation disorders present\n  6. An arterial\u002Fdeep vein thrombosis event occurred within 6 months prior to the first administration\n  7. Poor blood pressure control\n  8. Suffering from significant cardiovascular disease\n  9. There is an uncontrolled infection of ≥ CTC AE grade 2 within 14 days before the start of treatment\n  10. History of interstitial lung disease\u002Fpneumonia (non infectious) requiring steroid medication intervention in the past\n  11. Individuals with moderate to severe pulmonary dysfunction\u002Fdisease within 3 months prior to the first administration\n  12. Active viral hepatitis with poor control\n  13. Active syphilis infected individuals in need of treatment\n  14. Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation\n  15. Immunosuppressants or systemic or absorbable local hormone therapy are required to achieve immunosuppression\n  16. History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases\n  17. Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification\\>1.0 g\n  18. Patients with renal failure requiring hemodialysis or peritoneal dialysis\n  19. Poor control of diabetes\n  20. Individuals with epilepsy who require treatment\n  21. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders\n* Tumor related symptoms and treatment\n\n  1. There is a third interstitial fluid accumulation or cancerous lymphangitis that cannot be controlled by drainage or other methods\n  2. History of cumulative dose exposure to anthracyclines in the past\n  3. Received radiation therapy within 3 weeks prior to the start of study treatment and endocrine therapy within 2 weeks prior to the start of study treatment\n  4. Traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 weeks before the start of the study treatment\n* Research treatment related\n\n  1. Previously received antibody conjugate therapy consisting of topoisomerase I inhibitors,;\n  2. Allergic to any research drug or any ingredient or excipient in the drug;\n  3. Individuals who experience severe hypersensitivity reactions after using monoclonal antibodies;\n  4. Participated in other clinical trials of anti-tumor therapy within 4 weeks before the start of the research treatment.\n* According to the researcher's judgment, there are situations that seriously endanger the safety of the subjects or affect their ability to complete the study.","ALL","18 Years","75 Years",{"count":402,"type":403},642,"ESTIMATED","INTERVENTIONAL",[406],"PHASE3","This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or docetaxel combined with trastuzumab and pertuzumab, respectively.",[409],"Breast Cancer","2025-06-24",{"date":412,"type":413},"2025-06-25","ACTUAL",{"date":415,"type":413},"2025-06-23",{"date":417,"type":403},"2030-07",{"name":419,"class":6},"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.",25]