[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598292":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":61,"collaborators":63,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":28,"enrollmentInfo":79,"targetDuration":28,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":41,"whyStopped":28,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"UNC Lineberger Comprehensive Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with higher residual cancer burden","EXPERIMENTAL","Participants with stage II\u002FIII triple negative breast cancer (TNBC) and residual disease post-neoadjuvant therapy, particularly patients with higher residual cancer burden (RCB II\u002FIII), remain at high risk for developing recurrence.",[13,14],"Drug: Datopotamab deruxtecan","Diagnostic Test: Circulating tumor DNA (ctDNA) testing",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Datopotamab deruxtecan","Dato-DXd is administered adjuvantly at 6 mg\u002Fkg IV for eight cycles.",[9],[22],"Dato-DXd",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DIAGNOSTIC_TEST","Circulating tumor DNA (ctDNA) testing","Circulating tumor DNA (ctDNA) testing is a type of biopsy that analyzes fragments of DNA shed by cancer cells into the bloodstream. These fragments, known as ctDNA, can provide valuable information about the genetic makeup of a tumor without needing a traditional tissue biopsy.",[9],null,[30],{"name":31,"affiliation":5,"role":32},"Yara Abdou, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":28,"email":38},"Taylor Pierce","CONTACT","(919) 445-4827","Taylor_Pierce@med.unc.edu",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Chapel Hill","North Carolina","27514","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-79.05584,35.9132,{"lat":51,"lon":50},[54,58,60],{"name":55,"role":36,"phone":56,"phoneExt":28,"email":57},"Ana Gallegos","919-445-4827","ana_gallegos@med.unc.edu",{"name":35,"role":36,"phone":37,"phoneExt":28,"email":59},"tepierce@email.unc.edu",{"name":31,"role":32,"phone":28,"phoneExt":28,"email":28},{"type":62,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[64,67],{"name":65,"class":66},"AstraZeneca","INDUSTRY",{"name":68,"class":6},"Translational Breast Cancer Research Consortium","100598292","phase-2-predict-rd-ctdna-surveillance-in-tnbc-with-residual-disease-100598292",false,"NCT07069595","PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease","PREDICT-RD: Postoperative Molecular Residual Disease by ctDNA Surveillance in TNBC With Residual Disease","PREDICT-RD","Inclusion Criteria:\n\nWritten informed consent was obtained to participate in the study, and HIPAA authorization for the release of personal health information.\n\n* Participant is willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* Histological confirmation of TNBC defined by ER\u002FPR \\\u003C10%, HER2 0-1+ by IHC or 2+ by IHC and fluorescence in situ hybridization (FISH) negative.\n* Stage II\u002FIII TNBC treated with neoadjuvant systemic therapy AND have residual disease defined as RCB II\u002FIII at time of surgery.\n* Baseline staging scans at the discretion of the treating physician and demonstrate no evidence of metastatic disease.\n* The participant must have archival diagnostic tissue and\u002For surgical resection tissue Available.\n* Participants are willing and able to comply with study procedures based on the judgment of the investigator.\n\nExclusion Criteria:\n\n• Participants are pregnant or breastfeeding.","ALL","18 Years",{"count":80,"type":81},78,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","This is a Phase II, interventional, prospective, single-arm, multi-center study that will enroll patients with stage II\u002FIII triple negative breast cancer (TNBC) who have residual cancer burden (RCB) II\u002FIII after conventional neoadjuvant chemo-immunotherapy followed by surgery. Technological advances in ctDNA assays have improved both the sensitivity and reliability of molecular residual disease (MRD) detection to enable real-time measurement with clinical-grade assays.\n\nThe primary objective of this study will be to evaluate ctDNA-based MRD status in high-risk, early-stage TNBC patients by defining the proportion of TNBC patients with MRD-only recurrence (ctDNA positive without radiographically measurable recurrence) during post-surgery surveillance. The secondary objectives will evaluate the safety, preliminary efficacy, and survival outcomes of using Dato-DXd in participants with MRD-only TNBC.\n\nDato-DXd is an investigational antibody-drug conjugate (monoclonal antibody specific for TROP2 and a topoisomerase I (Topo-1) inhibitor) that has demonstrated promising efficacy in TNBC patients with a manageable safety profile.",[87,88,89,90],"Breast Cancer","Residual Disease","Triple Negative Breast Cancer (TNBC)","Stage II\u002FIII",[92,93,22],"circulating tumor DNA (ctDNA)","surveillance","2026-04-21",{"date":96,"type":97},"2026-04-22","ACTUAL",{"date":99,"type":97},"2026-02-26",{"date":101,"type":81},"2032-11-01",{"name":5,"class":6},1]