[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638118":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":26,"responsibleParty":55,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":10,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":85,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Gazi University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Early-stage breast cancer patients receiving systemic therapy",null,"Adult women with histologically confirmed Stage I-III breast cancer for whom neoadjuvant or adjuvant chemotherapy and\u002For HER2-targeted systemic therapy is planned, with baseline left ventricular ejection fraction ≥ 50%. Patients receive standard-of-care systemic therapy as determined by their treating oncologist; the study does not modify treatment selection, dose, or duration. For analytic purposes, patients are sub-grouped by chemotherapy regimen (anthracycline-containing vs. anthracycline-free) for comparative analyses of cardiac function and circulating microRNA changes.",[13],{"name":14,"affiliation":5,"role":15},"Fatih Gürler","PRINCIPAL_INVESTIGATOR",[17,22],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},"Sıla Soylu Koçoğlu, MD","CONTACT","+905012735223","drsilasoylu@gmail.com",{"name":23,"role":19,"phone":24,"phoneExt":10,"email":25},"Fatih Gürler, MD","+905325495597","drfatihgurler@gmail.com",[27],{"facility":28,"status":10,"city":29,"state":29,"zip":30,"country":31,"countryCode":10,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Gazi University Faculty of Medicine","Ankara","06560","Turkey (Türkiye)",{"type":33,"coordinates":34},"Point",[35,36],32.85427,39.91987,{"lat":36,"lon":35},[39,40,41,43,45,47,49,51,53],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},{"name":23,"role":15,"phone":10,"phoneExt":10,"email":10},{"name":18,"role":42,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":44,"role":42,"phone":10,"phoneExt":10,"email":10},"Ayşe Arslan Kapuci, MD",{"name":46,"role":42,"phone":10,"phoneExt":10,"email":10},"Serkan Ünlü, MD",{"name":48,"role":42,"phone":10,"phoneExt":10,"email":10},"Elif Nur Ayrancı, MD",{"name":50,"role":42,"phone":10,"phoneExt":10,"email":10},"Ahmet Eren Beşir, MD",{"name":52,"role":42,"phone":10,"phoneExt":10,"email":10},"Duygu Deniz Usta Salimi, PhD",{"name":54,"role":42,"phone":10,"phoneExt":10,"email":10},"Atiye Seda Yar, PhD",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Fatih GURLER","Principal Investigator","100638118","cardiac-side-effects-of-systemic-therapy-in-early-stage-breast-cancer-100638118",false,"NCT07588425","Cardiac Side Effects of Systemic Therapy in Early-Stage Breast Cancer","Prospective and Molecular Biomarker-Based Evaluation of Cardiac Side Effects in Patients With Early-Stage Breast Cancer Receiving Systemic Therapy: A Single-Center Observational Cohort Study","C-BREAST-01","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of breast cancer\n* Stage I, II, or III disease\n* Planned neoadjuvant or adjuvant chemotherapy and\u002For HER2-targeted systemic therapy\n* Baseline transthoracic echocardiographic left ventricular ejection fraction (LVEF) ≥ 50%\n* Age ≥ 18 years\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Metastatic (Stage IV) breast cancer\n* Pre-existing heart failure or clinically significant cardiac disease\n* Prior exposure to chemotherapy or other cardiotoxic systemic therapy\n* Concurrent active malignancy other than breast cancer\n* Inability or unwillingness to comply with the planned follow-up and assessment schedule","FEMALE","18 Years",{"count":70,"type":71},100,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate cardiac side effects in women with early-stage breast cancer who receive systemic chemotherapy and\u002For anti-HER2 therapy as part of their standard cancer care.\n\nThe main questions it aims to answer are:\n\nCan changes in Global Longitudinal Strain (GLS) on echocardiography detect early cardiac dysfunction before a drop in left ventricular ejection fraction (LVEF) becomes apparent? Are changes in circulating microRNA levels in the blood associated with early cardiac dysfunction during cancer treatment? Does cardiac dysfunction occur more frequently with anthracycline-containing chemotherapy compared to anthracycline-free regimens?\n\nParticipants already receiving standard chemotherapy and\u002For anti-HER2 therapy as part of their routine cancer care will undergo echocardiography (LVEF and GLS), provide blood samples for microRNA analysis, and complete quality of life questionnaires at four time points: before treatment (baseline), and at 3, 6, and 12 months after starting treatment.",[75,76,77],"Breast Cancer (Early Breast Cancer)","Cardiotoxicity","Cancer Therapy-Related Cardiac Dysfunction",[79,80,81,76,82,83,84],"Early-stage breast cancer","Anthracyclines","Anti-HER2 therapy","GLS","microRNA","Cardio-oncology","NOT_YET_RECRUITING","2026-05-10",{"date":88,"type":89},"2026-05-14","ACTUAL",{"date":86,"type":71},{"date":92,"type":71},"2028-03-30",{"name":57,"class":6},1]