[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100330569":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":27,"responsibleParty":191,"collaborators":26,"id":193,"slug":194,"hasResults":195,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":26,"eligibilityCriteria":199,"healthyVolunteers":195,"sex":200,"minAge":201,"maxAge":26,"enrollmentInfo":202,"targetDuration":26,"studyType":205,"phases":206,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":217,"whyStopped":26,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},{"fullName":5,"class":6},"Eisai Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Eribulin Mesylate 1.23 mg","EXPERIMENTAL","Participants will receive eribulin mesylate 1.23 mg intravenous (IV) infusion, given over 2 - 5 minutes on Days 1 and 8 of 21 days cycle for a total of 6 cycles.",[13],"Drug: Eribulin Mesylate",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Eribulin Mesylate","Eribulin mesylate IV infusion.",[9],[21],"Halaven",[23],{"name":24,"affiliation":5,"role":25},"Medical Director","STUDY_DIRECTOR",null,[28,41,51,57,66,76,85,94,104,114,124,134,144,154,163,169,179,185],{"facility":29,"status":26,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":26},"HEMATO-ONCOLOGY CLINIC Vedanta Institute of Medical Sciences","Ahmedabad","Gujarat","380009","India","IN",{"type":36,"coordinates":37},"Point",[38,39],72.58727,23.02579,{"lat":39,"lon":38},{"facility":42,"status":26,"city":43,"state":44,"zip":45,"country":33,"countryCode":34,"cosmosGeoPoint":46,"geoPoint":50,"contacts":26},"HealthCare Global Enterprises Ltd","Bangalore","Karnataka","560027",{"type":36,"coordinates":47},[48,49],77.59369,12.97194,{"lat":49,"lon":48},{"facility":52,"status":26,"city":43,"state":44,"zip":53,"country":33,"countryCode":34,"cosmosGeoPoint":54,"geoPoint":56,"contacts":26},"Srinivasam Cancer Care Multispecialty Hospitals India Pvt Ltd","560072",{"type":36,"coordinates":55},[48,49],{"lat":49,"lon":48},{"facility":58,"status":26,"city":59,"state":44,"zip":60,"country":33,"countryCode":34,"cosmosGeoPoint":61,"geoPoint":65,"contacts":26},"KR Hospital Mysore Medical College","Mysore","570001",{"type":36,"coordinates":62},[63,64],76.63925,12.29791,{"lat":64,"lon":63},{"facility":67,"status":26,"city":68,"state":69,"zip":70,"country":33,"countryCode":34,"cosmosGeoPoint":71,"geoPoint":75,"contacts":26},"Tata Memorial Hospital Department of Oncology","Mumbai","Maharashtra","400012",{"type":36,"coordinates":72},[73,74],72.88261,19.07283,{"lat":74,"lon":73},{"facility":77,"status":26,"city":78,"state":69,"zip":79,"country":33,"countryCode":34,"cosmosGeoPoint":80,"geoPoint":84,"contacts":26},"HCG NCHRI Cancer Centre","Nagpur","440026",{"type":36,"coordinates":81},[82,83],79.08491,21.14631,{"lat":83,"lon":82},{"facility":86,"status":26,"city":87,"state":69,"zip":88,"country":33,"countryCode":34,"cosmosGeoPoint":89,"geoPoint":93,"contacts":26},"Lokmanya Hospital","Pune","411033",{"type":36,"coordinates":90},[91,92],73.85535,18.51957,{"lat":92,"lon":91},{"facility":95,"status":26,"city":96,"state":97,"zip":98,"country":33,"countryCode":34,"cosmosGeoPoint":99,"geoPoint":103,"contacts":26},"Sir Ganga Ram Hospital","New Delhi","National Capital Territory of Delhi","110060",{"type":36,"coordinates":100},[101,102],77.2148,28.62137,{"lat":102,"lon":101},{"facility":105,"status":26,"city":106,"state":107,"zip":108,"country":33,"countryCode":34,"cosmosGeoPoint":109,"geoPoint":113,"contacts":26},"All India Institute of Medical Sciences","Bhubaneswar","Odisha","751019",{"type":36,"coordinates":110},[111,112],85.83385,20.27241,{"lat":112,"lon":111},{"facility":115,"status":26,"city":116,"state":117,"zip":118,"country":33,"countryCode":34,"cosmosGeoPoint":119,"geoPoint":123,"contacts":26},"Deep Hospital","Ludhiana","Punjab","141002",{"type":36,"coordinates":120},[121,122],75.85379,30.91204,{"lat":122,"lon":121},{"facility":125,"status":26,"city":126,"state":127,"zip":128,"country":33,"countryCode":34,"cosmosGeoPoint":129,"geoPoint":133,"contacts":26},"Sawai Man Singh Hospital","Jaipur","Rajasthan","302001",{"type":36,"coordinates":130},[131,132],75.78781,26.91962,{"lat":132,"lon":131},{"facility":135,"status":26,"city":136,"state":137,"zip":138,"country":33,"countryCode":34,"cosmosGeoPoint":139,"geoPoint":143,"contacts":26},"MNJ Institute of Oncology and Regional Cancer Centre","Hyderabad","Telangana","500004",{"type":36,"coordinates":140},[141,142],78.45636,17.38405,{"lat":142,"lon":141},{"facility":145,"status":26,"city":146,"state":147,"zip":148,"country":33,"countryCode":34,"cosmosGeoPoint":149,"geoPoint":153,"contacts":26},"J.K.Cancer Institute","Kanpur","Uttar Pradesh","208002",{"type":36,"coordinates":150},[151,152],80.34975,26.46523,{"lat":152,"lon":151},{"facility":155,"status":26,"city":156,"state":147,"zip":157,"country":33,"countryCode":34,"cosmosGeoPoint":158,"geoPoint":162,"contacts":26},"King George's Medical University,(Erstwhile Chhatrapati Shahuji Maharaj Medical University)","Lucknow","226003",{"type":36,"coordinates":159},[160,161],80.92313,26.83928,{"lat":161,"lon":160},{"facility":164,"status":26,"city":156,"state":147,"zip":165,"country":33,"countryCode":34,"cosmosGeoPoint":166,"geoPoint":168,"contacts":26},"Ajanta Research Centre, Ajanta Hospital & IVF Centre","226005",{"type":36,"coordinates":167},[160,161],{"lat":161,"lon":160},{"facility":170,"status":26,"city":171,"state":172,"zip":173,"country":33,"countryCode":34,"cosmosGeoPoint":174,"geoPoint":178,"contacts":26},"Nilratan Sircar Medical College and Hospital","Kolkata","West Bengal","700014",{"type":36,"coordinates":175},[176,177],88.36304,22.56263,{"lat":177,"lon":176},{"facility":180,"status":26,"city":171,"state":172,"zip":181,"country":33,"countryCode":34,"cosmosGeoPoint":182,"geoPoint":184,"contacts":26},"Netaji Subhash Chandra Bose Cancer Institute","700016",{"type":36,"coordinates":183},[176,177],{"lat":177,"lon":176},{"facility":186,"status":26,"city":171,"state":172,"zip":187,"country":33,"countryCode":34,"cosmosGeoPoint":188,"geoPoint":190,"contacts":26},"IPGME&R S.S.K.M Hospital","700020",{"type":36,"coordinates":189},[176,177],{"lat":177,"lon":176},{"type":192,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100330569","phase-4-a-study-to-evaluate-safety-tolerability-and-efficacy-of-eribulin-mesylate-in-treating-adult-females-with-locally-advanced-or-metastatic-breast-cancer-100330569",false,"NCT03583944","A Study to Evaluate Safety, Tolerability and Efficacy of Eribulin Mesylate in Treating Adult Females With Locally Advanced or Metastatic Breast Cancer","Post Marketing Trial (Phase IV) on the Safety, Tolerability And Efficacy of Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n1. Participants with locally advanced or metastatic breast cancer.\n2. Participants must have progressed after at least after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an Anthracycline and a Taxane unless participants who are not suitable for these treatments.\n3. Participants must have documented disease progression within or on 6 months from their last anti-cancer therapy.\n4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\\\u003C=) 2.\n5. Participants must have normal organ and marrow function as defined below:\n\n   * Absolute neutrophil count greater than (\\>) 1,500 per microliter (\u002FmcL)\n   * Hemoglobin \\>10.0 gram per deciliter (g\u002FdL)\n   * Platelets \\>100,000\u002Fmcl\n   * Serum total bilirubin less than (\\\u003C) 1.5\\*upper limit of normal (ULN)\n   * Serum aspartate aminotransferase (AST) (Serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (Serum glutamic pyruvic transaminase \\[SGPT\\]) \\\u003C3\\*ULN or \\\u003C5\\*ULN in the presence of liver metastases\n   * Serum creatinine \\\u003C1.5 mg\u002FdL.\n6. Females in reproductive age willing to follow adequate barrier contraceptive measures during the conduct of study.\n\nExclusion Criteria:\n\n1. Hypersensitivity to the active substance or any of the excipients.\n2. Participants who have received chemotherapy, radiation, or biological therapy within two weeks, or hormonal therapy within one week before study treatment start, or any investigational drug within four weeks before study treatment start.\n3. Participants receiving any other investigational agents.\n4. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, or other comorbid condition that investigator believes may compromise participant's condition.\n5. Participants requiring concurrent anti-cancer therapy during the study period.\n6. Participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting study treatment.","FEMALE","18 Years",{"count":203,"type":204},200,"ACTUAL","INTERVENTIONAL",[207],"PHASE4","The purpose of this study is to evaluate clinical and laboratory safety of eribulin mesylate in treating participants with locally advanced or metastatic breast cancer, who have progressed after at least one regimen of chemotherapy which has included anthracycline and taxane therapy.",[210],"Breast Neoplasms",[212,213,214,215,216],"E7389","Tumors, Breast","Breast Cancer","Breast Carcinoma","Neoplasms, Breast","COMPLETED","2019-11-26",{"date":220,"type":204},"2019-11-27",{"date":222,"type":204},"2018-03-28",{"date":224,"type":204},"2019-06-28",{"name":5,"class":6},18]