[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100417997":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":62,"collaborators":41,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":41,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":41,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":41,"overallStatus":46,"whyStopped":41,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","ACTIVE_COMPARATOR","Gemcitabine combined with carboplatin plus moxifloxacin",[13],"Drug: Gemcitabine and carboplatin plus antibiotic (moxifloxacin)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","PLACEBO_COMPARATOR","Gemcitabine combined with carboplatin plus placebo",[19],"Drug: Gemcitabine combined with carboplatin plus placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Gemcitabine and carboplatin plus antibiotic (moxifloxacin)","Standard chemotherapy (gemcitabine and carboplatin) plus antibiotic (moxifloxacin)",[9],[27],"Gemcitabine 1000mg\u002Fm^2 IV on days 1 and 8; cycled every 21 days Carboplatin AUC 2 IV on days 1 and 8; cycled every 21 days Moxifloxacin 0.4 PO once daily days 1-5; cycled every 21 days",{"type":22,"name":17,"description":29,"armGroupLabels":30,"otherNames":31},"Standard chemotherapy (gemcitabine and carboplatin) plus placebo",[15],[32],"Gemcitabine 1000mg\u002Fm^2 IV on days 1 and 8; cycled every 21 days Carboplatin AUC 2 IV on days 1 and 8; cycled every 21 days Placebo 0.4 PO once daily days 1-5; cycled every 21 days",[34],{"name":35,"affiliation":5,"role":36},"Zhong-yu Yuan, M.D.","STUDY_CHAIR",[38],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","862087342794",null,"yuanzhy@sysucc.org.cn",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":53,"coordinates":54},"Point",[55,56],113.25,23.11667,{"lat":56,"lon":55},[59],{"name":60,"role":39,"phone":61,"phoneExt":41,"email":42},"Zhong-yu Yuan, MD","86-20-87343794",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":66,"oldNameTitle":41,"oldOrganization":41},"PRINCIPAL_INVESTIGATOR","Zhong-yu Yuan","Clinical Professor","Sun Yat-Sen University Cancer Center","100417997","phase-3-standard-chemotherapy-plus-moxifloxacin-as-first-line-treatment-for-metastatic-triple-negative-breast-cancer-100417997",false,"NCT04722978","Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer","Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer : a Multicenter, Double-blind, Placebo-controlled, Phase 3 Trial","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.\n* Histologically confirmed invasive ductal carcinoma, no specific type (NOS)\n* ER negative and progesterone receptor (PR) negative (defined as \\\u003C 1% positive cells by IHC), human epidermal growth factor receptor 2 (HER2) negative (defined as IHC 0-1 staining or fluorescent in situ hybridization (FISH) negative).\n* No prior therapy after first recurrence or diagnosis of metastatic disease.\n* At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.\n* Neutrophil-to-lymphocyte ratios (NLR) in peripheral blood ≥ 2.\n* Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve (Left ventricular ejection fraction (LVEF) by echocardiogram ≥45%).\n* Compliance with the study protocol.\n* Have provided written and signed informed consent.\n\nExclusion Criteria:\n\n* Pregnant or breast feeding.\n* Definitive breast cancer susceptibility gene (BRCA) mutation, Programmed Cell Death-Ligand 1 (PD-L1) positive, microsatellite instability-high (MSI-H), and mismatch repair deficient (dMMR).\n* Patients who are receiving or will receive other biological agents or immunotherapy.\n* Uncontrolled medical problems.\n* Evidence of active acute or chronic infection.\n* Hepatic, renal, cardiac, or bone marrow dysfunction as detailed above.\n* Concurrent malignancy or history of other malignancy within the last five years.\n* Known severe hypersensitivity to moxifloxacin\n* Patients were unable or unwilling to comply with program requirements.","FEMALE","18 Years","70 Years",{"count":78,"type":79},228,"ESTIMATED","INTERVENTIONAL",[82],"PHASE3","The primary objective of this study is to compare progression-free survival (PFS) of patients with metastatic triple-negative breast cancer randomised to treatment with standard chemotherapy plus moxifloxacin or placebo.",[85],"Triple Negative Breast Cancer","2025-12-10",{"date":88,"type":89},"2025-12-17","ACTUAL",{"date":91,"type":89},"2021-04-20",{"date":93,"type":79},"2026-07",{"name":66,"class":6},1]