[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542257":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":28,"locations":33,"responsibleParty":49,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":20,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":20,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Vastra Gotaland Region","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NT-proBNP instead of ECHO\u002FMUGA at 6 months and 12 months","EXPERIMENTAL","Replacement with measurement of plasma levels of NT-proBNP at 6 months and 12 months instead of ECHO\u002FMUGA for monitoring of trastuzumab-induced cardiotoxicity",[13],"Diagnostic Test: Plasma NT-proBNP",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","Plasma NT-proBNP","Replacement of measurement of plasma NT-proBNP instead of ECHO\u002FMUGA at 6 months and 12 months of trastuzumab treatment to assess cardiotoxicity",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Daniel Giglio, Assoc Prof","Sahlgrenska University Hospital\u002FUniversity of Gothenburg","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":24,"role":25},"Barbro Linderholm, Assoc Prof",[29],{"name":23,"role":30,"phone":31,"phoneExt":20,"email":32},"CONTACT","+46(0)31-342 16 06","daniel.giglio@pharm.gu.se",[34],{"facility":35,"status":36,"city":37,"state":20,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Jubileumskliniken, Sahlgrenska University Hospital","RECRUITING","Gothenburg","432 45","Sweden","SE",{"type":42,"coordinates":43},"Point",[44,45],11.96679,57.70716,{"lat":45,"lon":44},[48],{"name":23,"role":30,"phone":31,"phoneExt":20,"email":32},{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100542257","nt-probnp-to-assess-trastuzumab-induced-cardiotoxicity-100542257",false,"NCT06340516","NT-proBNP to Assess Trastuzumab-induced Cardiotoxicity","Monitoring Heart Function Through Blood Test Analysis of NT-proBNP During Treatment With HER2-Targeted Antibodies in HER2-Positive Breast Cancer - A Swedish Multicenter Study","Inclusion Criteria:\n\n1. Histological confirmed HER2 positive primary BC planned for adjuvant\u002Fneoadjuvant treatment with chemotherapy plus HER2 blocking agents.\n2. Patients ≥18 years\n3. ECOG\u002FWHO 0-1\n4. Adequate organ function for the planned treatment according to local guidelines.\n5. No distant metastasis (CT\u002FMRI only if clinically indicated).\n6. Negative pregnancy test within 14 days prior to start of treatment.\n7. If of childbearing potential, willing to use an effective form of contraception.\n8. No other malignancy during the last 5 years except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix.\n9. Signed informed consent and willingness to follow the trial procedures.\n\nExclusion Criteria:\n\n1. Patients with previous heart disease recommended special follow-up during treatment with high risk of termination of treatment.\n2. Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance.\n3. Pregnancy and breast feeding.\n4. Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).\n\n   \\-","ALL","18 Years",{"count":61,"type":62},700,"ESTIMATED","INTERVENTIONAL",[65],"NA","Trastuzumab-induced cardiotoxicity (TIC) will be monitored in patients with HER2+ breast cancer undergoing trastuzumab treatment before and after breast cancer surgery. At baseline before start of trastuzumab treatment, echocardiography (ECHO)\u002Fmultigated Acquisition Scan (MUGA) and measurement of plasma NT-proBNP will be performed. NT-proBNP will be measured again at 6 months and at 12 months of trastuzumab treatment. If elevations in NT-proBNP at 6 months and 12 months occur patients will be referred for ECHO\u002FMUGA. The aim is to assess the sensitivity and specificity to detect TIC with NT-proBNP and whether ECHO\u002FMUGA can be safely replaced by assessment of plasma NT-proBNP levels.",[68,69,70],"Cardiotoxicity","Breast Cancer","Treatment Side Effects","2024-03-29",{"date":73,"type":74},"2024-04-01","ACTUAL",{"date":76,"type":74},"2024-03-14",{"date":78,"type":62},"2029-03-14",{"name":5,"class":6},1]