[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632664":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":23,"responsibleParty":33,"collaborators":10,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":10,"enrollmentInfo":46,"targetDuration":10,"studyType":49,"phases":10,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":62,"whyStopped":10,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Atlas University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Locally Advanced Breast Cancer Patients Cohort",null,"Adult female patients diagnosed with locally advanced breast cancer and scheduled to receive standard neoadjuvant chemotherapy. Tumor tissue and blood samples obtained during routine clinical care will be used to generate patient-derived organoid models and to perform biomarker analyses. No experimental intervention will be applied to participants.",[13],{"name":14,"affiliation":15,"role":16},"Emine Yildirim","Istanbul Atlas University Faculty of Medicine","PRINCIPAL_INVESTIGATOR",[18],{"name":19,"role":20,"phone":21,"phoneExt":10,"email":22},"Emine Yildirim, MD","CONTACT","+905056234825","emine.yildirim@atlas.edu.tr",[24],{"facility":15,"status":10,"city":25,"state":10,"zip":10,"country":26,"countryCode":10,"cosmosGeoPoint":27,"geoPoint":32,"contacts":10},"Istanbul","Turkey (Türkiye)",{"type":28,"coordinates":29},"Point",[30,31],28.94966,41.01384,{"lat":31,"lon":30},{"type":16,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Emine YILDIRIM","Associate Professor of General Surgery, Head of the Department of General Surgery","100632664","patient-derived-organoids-to-functionally-characterize-chemotherapy-resistance-in-breast-cancer-100632664",false,"NCT07516626","Patient-Derived Organoids to Functionally Characterize Chemotherapy Resistance in Breast Cancer","Functional Characterization of Neoadjuvant Chemotherapy Resistance in Breast Cancer Using Patient-Derived Organoid Models and Development of Drug Repurposing Strategies With Next-Generation Small Molecules","BC-PDO","Inclusion Criteria:\n\n* Female patients aged 18 years or older\n* Histologically confirmed locally advanced breast cancer\n* Planned to receive neoadjuvant chemotherapy\n* Availability of tumor tissue obtained during routine diagnostic or therapeutic procedures\n* Availability of clinical and pathological treatment data\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Age under 18 years\n* Metastatic breast cancer\n* Prior systemic chemotherapy or targeted therapy for the current diagnosis\n* Presence of another active malignancy\n* Severe comorbid conditions that may interfere with study participation\n* Insufficient biological sample for organoid generation or analysis\n* Inability or unwillingness to provide informed consent","FEMALE","18 Years",{"count":47,"type":48},40,"ESTIMATED","OBSERVATIONAL","This prospective observational study aims to functionally characterize chemotherapy resistance in patients with locally advanced breast cancer undergoing neoadjuvant chemotherapy. Despite standard molecular classification, significant heterogeneity in treatment response exists, and the biological mechanisms underlying chemoresistance remain incompletely understood.\n\nIn this study, patient-derived organoid (PDO) models will be established from tumor tissues obtained during routine clinical care. These three-dimensional models preserve the biological characteristics of individual tumors and enable ex vivo functional assessment of drug response. Chemotherapy sensitivity and resistance will be evaluated using quantitative parameters including Half-Maximal Inhibitory Concentration (IC50) values, cell viability, and apoptotic response.\n\nFunctional data obtained from PDO models will be correlated with clinical and pathological treatment outcomes, particularly pathological complete response (pCR), to assess the predictive value of PDO-based assays. In addition, apoptotic biomarkers such as Caspase-3\u002F7 will be measured in serum samples collected during routine clinical evaluation and analyzed in relation to treatment response.\n\nFurthermore, selected Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved small molecules will be tested in PDO models to evaluate their potential to reverse chemotherapy resistance, supporting drug repurposing strategies. This study aims to establish a functional, patient-specific platform for assessing chemoresistance and to contribute to the development of personalized therapeutic approaches in breast cancer.",[52,53],"Breast Cancer","Locally Advanced Breast Cancer (LABC)",[55,56,57,58,59,60,61],"Neoadjuvant Chemotherapy","Chemotherapy Resistance","Patient-Derived Organoids","Drug Repurposing","Pathological Complete Response","Ex Vivo Drug Testing","Locally Advanced Breast Cancer","NOT_YET_RECRUITING","2026-04-07",{"date":65,"type":66},"2026-04-13","ACTUAL",{"date":68,"type":48},"2026-06",{"date":70,"type":48},"2029-06",{"name":5,"class":6},1]