[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509694":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":10,"centralContacts":10,"locations":64,"responsibleParty":83,"collaborators":10,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":10,"enrollmentInfo":95,"targetDuration":10,"studyType":98,"phases":10,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":66,"whyStopped":10,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Vall d'Hebron Institute of Oncology","OTHER",[8,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A",null,"Pembrolizumab + neoadjuvant chemotherapy",[13,14,15,16,17,18,19,20],"Diagnostic Test: Whole Genome Sequencing","Diagnostic Test: RNA-Sequencing","Diagnostic Test: Microbiome analysis","Diagnostic Test: ctDNA analysis","Diagnostic Test: TCR-β repertoire sequencing","Diagnostic Test: PBMCs phenotyping","Drug: Pembrolizumab","Drug: Chemotherapy",{"label":22,"type":10,"description":23,"interventionNames":24},"Cohort B","Neoadjuvant chemotherapy",[13,14,15,16,17,18,20],[26,33,37,41,45,49,53,58],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DIAGNOSTIC_TEST","Whole Genome Sequencing","Whole genome sequencing (WGS) will be performed in tumor tissue from baseline and from residual disease after neoadjuvant chemotherapy (NACT), if present.",[9,22],[32],"WGS",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"RNA-Sequencing","RNA-Sequencing will be performed in tumor tissue from baseline and from residual disease after NACT (if present).",[9,22],{"type":27,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"Microbiome analysis","Microbiome analysis will be performed in stools and saliva before, during NACT and at the end of adjuvant systemic therapy if adjuvant systemic therapy is clinically indicated.",[9,22],{"type":27,"name":42,"description":43,"armGroupLabels":44,"otherNames":10},"ctDNA analysis","ctDNA analysis will be performed in plasma before and during NACT.",[9,22],{"type":27,"name":46,"description":47,"armGroupLabels":48,"otherNames":10},"TCR-β repertoire sequencing","TCR-β repertoire sequencing will be performed in plasma before and during NACT.",[9,22],{"type":27,"name":50,"description":51,"armGroupLabels":52,"otherNames":10},"PBMCs phenotyping","PBMCs phenotyping will be performed in plasma before and during NACT.",[9,22],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":10},"DRUG","Pembrolizumab","Pembrolizumab will be given in combination with standard NACT.",[9],{"type":54,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Chemotherapy","Standard NACT will be given.",[9,22],[63],"Carboplatin, taxane, anthracycline, cyclophosphamide",[65],{"facility":5,"status":66,"city":67,"state":10,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"RECRUITING","Barcelona","08035","Spain","ES",{"type":72,"coordinates":73},"Point",[74,75],2.15899,41.38879,{"lat":75,"lon":74},[78],{"name":79,"role":80,"phone":81,"phoneExt":10,"email":82},"Mafalda Oliveira, MD PhD","CONTACT","+34932543450","moliveira@vhio.net",{"type":84,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100509694","predictive-biomarkers-of-response-to-checkpoint-inhibitors-in-triple-negative-breast-cancer-a-multiomics-platform-100509694",false,"NCT05916755","Predictive Biomarkers of Response to Checkpoint Inhibitors in Triple Negative Breast Cancer: a Multiomics Platform","Identification of Predictive Biomarkers of Response to Chemotherapy and Immune Checkpoint Inhibitors in Early Triple Negative Breast Cancer: an Integrative Multiomics Platform","PORTRAIT","Inclusion Criteria:\n\n* Histologically documented TNBC (negative human epidermal growth factor receptor 2 \\[HER2\\], estrogen receptor \\[ER\\], and progesterone receptor \\[PgR\\] status)\n* Stage 2 - 3 defined by the American Joint Committee of Cancer (AJCC) staging criteria 8th edition for breast cancer as assessed by the investigator based on radiological and\u002For clinical assessment\n* Patient is a candidate to receive NACT with or without ICI as assessed by the investigator\n* Patient is ≥ 18 years old at the time of consent to participate in this trial\n\nExclusion Criteria:\n\n* Metastatic disease on imaging (stage 4)","ALL","18 Years",{"count":96,"type":97},100,"ESTIMATED","OBSERVATIONAL","Patients with stage II-III Triple negative breast cancer (TNBC) candidates to receive neoadjuvant chemotherapy (NACT) +\u002F- immune checkpoint inhibitor (ICI) will be included. Several samples from different tissues will be analyzed through different omics to establish predictive biomarkers of response to the treatment. Multiple algorithms will then be used to look for an integrative predictive algorithm that incorporates multi-parameter inputs in order to develop a clinical tool to assist clinicians in the process of treatment decision-making in TNBC.",[101],"Triple Negative Breast Cancer",[103,104,105,106,107,108,109,110,111,34,112,32],"Circulating biomarkers","clinical tool","immune checkpoint inhibitors","integrative algorithm","microbiome","multiomics","neoadjuvant chemotherapy","predictive biomarkers","radiomics","triple negative breast cancer","2023-06-20",{"date":115,"type":116},"2023-06-23","ACTUAL",{"date":118,"type":116},"2023-01-13",{"date":120,"type":97},"2029-12",{"name":5,"class":6},1]