[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396058":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":44,"responsibleParty":62,"collaborators":19,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":19,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":19,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":47,"whyStopped":19,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},{"fullName":5,"class":6},"ChineseAMS","UNKNOWN",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Adjuvant chemotherapy","EXPERIMENTAL","Adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and\u002For positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy.\n\nAdjuvant chemotherapy regiments: Epirubicin 80-90mg\u002Fm2 IV or Pirarubicin 50mg\u002Fm2 IV + Cyclophosphamide 600mg\u002Fm2 IV, q21d\\*4cycles.",[13,14],"Drug: Epirubicin or Pirarubicin","Drug: Cyclophosphamide",{"label":16,"type":17,"description":18,"interventionNames":19},"Observation","NO_INTERVENTION","No adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and\u002For positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy.",null,[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Epirubicin or Pirarubicin","Epirubicin 80-90mg\u002Fm2 IV or Pirarubicin 50mg\u002Fm2 IV, q21d\\*4cycls",[9],[27],"EPI or THP",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Cyclophosphamide","Cyclophosphamide 600mg\u002Fm2 IV, q21d\\*4cycls",[9],[33],"CTX",[35],{"name":36,"affiliation":37,"role":38},"Pin ZHANG, MD","Chinese Academy of Medical Sciences","PRINCIPAL_INVESTIGATOR",[40],{"name":36,"role":41,"phone":42,"phoneExt":19,"email":43},"CONTACT","008601-87788120","Zhang_pin@sina.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)","RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":54,"coordinates":55},"Point",[56,57],116.39723,39.9075,{"lat":57,"lon":56},[60],{"name":36,"role":41,"phone":61,"phoneExt":19,"email":43},"13701275563",{"type":38,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":37,"oldNameTitle":19,"oldOrganization":19},"Pin Zhang","Clinical Professor","100396058","phase-2-adjuvant-chemotherapy-for-triple-negative-breast-cancer-patients-with-residual-disease-after-neoadjuvant-chemotherapy-100396058",false,"NCT04437160","Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy","A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Efficacy and Safety of Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Platinum-based Neoadjuvant Chemotherapy","Inclusion Criteria:\n\n* Patients with histologically confirmed invasive adenocarcinoma of the breast.\n* Triple negative breast cancer: hormone receptor negative (ER \\\u003C 10% and PgR \\\u003C 10%) and HER2 negative (IHC 0\u002F1+ or ISH non-amplified), as defined by the local pathology laboratory.\n* Clinical stage at presentation: T1-4, N0-3, M0, with indications for neoadjuvant chemotherapy.\n* Patient must have received platinum and taxanes neoadjuvant chemotherapy for at least 4 cycles and no tumor progression occurred.\n* Patients should have undergone adequate tumor excision in the breast and lymph nodes after neoadjuvant chemotherapy.\n* Residual invasive disease must be ≥1cm in the breast, and\u002For have positive axillary lymph nodes observed on pathologic exam after neoadjuvant chemotherapy.\n* ECOG Performance Status: 0-1.\n* Patients without severe heart, lung, liver and kidney disease.\n* Adequate hematologic and end-organ function.\n* No more than 6 weeks may elapse between definitive breast surgery and randomization.\n\nExclusion Criteria:\n\n* Previous neoadjuvant chemotherapy with anthracycline or other drugs (except platinum and taxanes).\n* Previous neoadjuvant chemotherapy with platinum or taxanes alone.\n* Patients have received other adjuvant therapy.\n* Comprehensive medical examinations have revealed distant metastases before randomization.\n* Patients who are not suitable for anthracycline evaluated by investigators.\n* Prior history of other malignancy (except carcinoma in situ).","ALL","18 Years","75 Years",{"count":76,"type":77},286,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","This study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy compared with observation in triple negative breast cancer (TNBC) patients with residual invasive disease after platinum and taxanes based neoadjuvant chemotherapy.",[83],"Triple Negative Breast Cancer",[85,86,87,9],"Triple negative breast cancer","Neoadjuvant chemotherapy","Residual invasive breast cancer","2020-06-16",{"date":90,"type":91},"2020-06-18","ACTUAL",{"date":93,"type":91},"2020-02-01",{"date":95,"type":77},"2027-12",{"name":37,"class":97},"OTHER",1]