[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396058":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":31,"studyPopulation":24,"armGroups":32,"interventions":44,"overallOfficials":58,"centralContacts":63,"locations":68,"responsibleParty":86,"collaborators":24,"id":89,"slug":24,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":24,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":24,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":71,"whyStopped":24,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},{"fullName":5,"class":6},"ChineseAMS","UNKNOWN",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"RFS","RFS defined as the time from randomization to the first recurrence event or death through the end of study","median 5 years",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"OS","OS defined as the time from randomization to all-cause death through the end of study",{"measure":18,"description":19,"timeFrame":20},"Percentage of patients with adverse events","To assess the toxicity of adjuvant chemotherapy by CTCAE v5.0","2-3 years",{"measure":22,"description":23,"timeFrame":20},"Changes in patient-reported quality of life","To assess the mean changes from baseline score in patient-reported quality of life using EORTC QLQ-C30",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":30,"maskingDescription":24,"whoMasked":24},"NONE","This study is a multi-center, randomized, phase II study. TNBC patients with residual invasive disease (invasive breast tumor size≥1cm and\u002For positive axillary lymph nodes) after platinum and taxanes based neoadjuvant chemotherapy are enrolled (n = 286). Patients are assigned to the chemotherapy group or the observation group at a 1:1 ratio randomly 4-6 weeks after surgery. Patients in the chemotherapy group are given anthracycline combined with cyclophosphamide regimen for 4 cycles. At the same time, the blood and tissue samples are collected for relevant tests. Follow up every 3-6 months and record recurrences and deaths.",[33,40],{"label":34,"type":35,"description":36,"interventionNames":37},"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.",[38,39],"Drug: Epirubicin or Pirarubicin","Drug: Cyclophosphamide",{"label":41,"type":42,"description":43,"interventionNames":24},"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.",[45,52],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"DRUG","Epirubicin or Pirarubicin","Epirubicin 80-90mg\u002Fm2 IV or Pirarubicin 50mg\u002Fm2 IV, q21d\\*4cycls",[34],[51],"EPI or THP",{"type":46,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"Cyclophosphamide","Cyclophosphamide 600mg\u002Fm2 IV, q21d\\*4cycls",[34],[57],"CTX",[59],{"name":60,"affiliation":61,"role":62},"Pin ZHANG, MD","Chinese Academy of Medical Sciences","PRINCIPAL_INVESTIGATOR",[64],{"name":60,"role":65,"phone":66,"phoneExt":24,"email":67},"CONTACT","008601-87788120","Zhang_pin@sina.com",[69],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)","RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":78,"coordinates":79},"Point",[80,81],116.39723,39.9075,{"lat":81,"lon":80},[84],{"name":60,"role":65,"phone":85,"phoneExt":24,"email":67},"13701275563",{"type":62,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":61,"oldNameTitle":24,"oldOrganization":24},"Pin Zhang","Clinical Professor","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":99,"type":100},286,"ESTIMATED","INTERVENTIONAL",[103],"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.",[106],"Triple Negative Breast Cancer",[108,109,110,34],"Triple negative breast cancer","Neoadjuvant chemotherapy","Residual invasive breast cancer","2020-06-16",{"date":113,"type":114},"2020-06-18","ACTUAL",{"date":116,"type":114},"2020-02-01",{"date":118,"type":100},"2027-12",{"name":61,"class":120},"OTHER",1]