[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636810":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":32,"responsibleParty":47,"collaborators":10,"id":49,"slug":10,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":10,"enrollmentInfo":57,"targetDuration":10,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":67,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Center Eugene Marquis","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Triple Negative Breast Cancer",null,"The study will include an initial assessment and longitudinal and individual follow-up to identify the occurrence of clinical events of interest and to monitor the evolution of any tumour biomarkers on circulating tumour DNA.",[13],"Biological: Additionnal breast biospy and blood sample",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"BIOLOGICAL","Additionnal breast biospy and blood sample","Tumor biopsy during intra-tumoral clip placement (pre-treatment) and annual blood samples (20 mL) for 5 years, in addition to standard follow-up.",[9],[21],{"name":22,"affiliation":23,"role":24},"Antoine DELEUZE, Dr","Centre de lutte contre le cancer Eugène Marquis","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Valérie JOLAINE","CONTACT","0299253036","+33","v.jolaine@rennes.unicancer.fr",[33],{"facility":34,"status":10,"city":35,"state":10,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Centre Eugène Marquis","Rennes","35000","France",{"type":39,"coordinates":40},"Point",[41,42],-1.67431,48.11109,{"lat":42,"lon":41},[45],{"name":22,"role":28,"phone":10,"phoneExt":10,"email":46},"a.deleuze@rennes.unicancer.fr",{"type":48,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100636810",false,"NCT07570524","Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer","PRIME-TNBC","Inclusion Criteria:\n\n* Female.\n* Age ≥ 18 years.\n* Histologically confirmed invasive triple-negative breast cancer (ER and PR \\\u003C 10% by IHC, HER2 0, 1+, or 2+ with negative SISH), stage II or III.\n* Eligible for neoadjuvant immunochemotherapy according to the Keynote-522 regimen.\n\nIndication for intra-tumoral clip placement.\n\n\\- Signed written informed consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Hematoma requiring Grade II analgesics after diagnostic biopsy.\n* Known coagulation disorders.\n* Adults under guardianship, curatorship, or legal protection, or deprived of liberty.\n* Not affiliated with a social security system.","FEMALE","18 Years",{"count":58,"type":59},200,"ESTIMATED","OBSERVATIONAL","The goal of this clinical trial is to identify cellular and molecular determinants of response to neoadjuvant immunochemotherapy in women aged 18 or older with early-stage triple-negative breast cancer (TNBC). The main questions it aims to answer are:\n\n* Can detailed immune profiling of the tumor and its microenvironment predict pathological complete response (pCR, RCB-0) versus partial\u002Fnon-response (RCB-I, II, III) to neoadjuvant immunochemotherapy?\n* Are there specific immune or molecular biomarkers (e.g., TILs, CD3\u002F8\u002F20, FoxP3, PDL1, transcriptomic signatures) associated with progression-free survival and overall survival in this population? Researchers will compare patients achieving pCR (RCB-0) to those with residual disease (RCB-I, II, III) to determine if immune and molecular profiles can discriminate responders from non-responders and guide personalized treatment strategies.",[63],"Triple-negative Breast Cancer (TNBC)",[65,66],"Biopsy","Residual Cancer Burden score","NOT_YET_RECRUITING","2026-04-30",{"date":70,"type":71},"2026-05-06","ACTUAL",{"date":73,"type":59},"2026-06-01",{"date":75,"type":59},"2036-05-31",{"name":5,"class":6},1]