[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100417997":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":26,"studyPopulation":13,"armGroups":27,"interventions":40,"overallOfficials":53,"centralContacts":57,"locations":62,"responsibleParty":81,"collaborators":13,"id":86,"slug":13,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":13,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":13,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":13,"overallStatus":65,"whyStopped":13,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"progression-free survival (PFS)","The interval from the date of randomization until the first date on which progression, or death due to any cause","36 months",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","Gemcitabine combined with carboplatin plus moxifloxacin or placebo","TREATMENT",{"masking":20,"maskingDescription":13,"whoMasked":21},"QUADRUPLE",[22,23,24,25],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a multicenter, randomised, double-blind, placebo-controlled, phase 3 trial. The main purposes of this study are to examine the efficacy and safety of standard chemotherapy plus moxifloxacin or placebo as first-line treatment in patients with metastatic triple-negative breast cancer. This study is designed to recruit up to 228 subjects.",[28,34],{"label":29,"type":30,"description":31,"interventionNames":32},"Experimental group","ACTIVE_COMPARATOR","Gemcitabine combined with carboplatin plus moxifloxacin",[33],"Drug: Gemcitabine and carboplatin plus antibiotic (moxifloxacin)",{"label":35,"type":36,"description":37,"interventionNames":38},"Control group","PLACEBO_COMPARATOR","Gemcitabine combined with carboplatin plus placebo",[39],"Drug: Gemcitabine combined with carboplatin plus placebo",[41,48],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","Gemcitabine and carboplatin plus antibiotic (moxifloxacin)","Standard chemotherapy (gemcitabine and carboplatin) plus antibiotic (moxifloxacin)",[29],[47],"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":42,"name":37,"description":49,"armGroupLabels":50,"otherNames":51},"Standard chemotherapy (gemcitabine and carboplatin) plus placebo",[35],[52],"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",[54],{"name":55,"affiliation":5,"role":56},"Zhong-yu Yuan, M.D.","STUDY_CHAIR",[58],{"name":55,"role":59,"phone":60,"phoneExt":13,"email":61},"CONTACT","862087342794","yuanzhy@sysucc.org.cn",[63],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":72,"coordinates":73},"Point",[74,75],113.25,23.11667,{"lat":75,"lon":74},[78],{"name":79,"role":59,"phone":80,"phoneExt":13,"email":61},"Zhong-yu Yuan, MD","86-20-87343794",{"type":82,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":85,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Zhong-yu Yuan","Clinical Professor","Sun Yat-Sen University Cancer Center","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":96,"type":97},228,"ESTIMATED","INTERVENTIONAL",[100],"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.",[103],"Triple Negative Breast Cancer","2025-12-10",{"date":106,"type":107},"2025-12-17","ACTUAL",{"date":109,"type":107},"2021-04-20",{"date":111,"type":97},"2026-07",{"name":85,"class":6},1]