[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596719":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":32,"responsibleParty":48,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"European Institute of Oncology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HER2-positive or HER2- low\u002Fultralow metastatic patient",null,"Candidate to receive T-DXd as per standard practice for HER2-positive or HER2- low\u002Fultralow advanced breast cancer.",[13],"Other: T-DXd toxicity marker identification",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"T-DXd toxicity marker identification","to find potential predictive markers associated with T-DXd-related toxicities",[9],[20],{"name":21,"affiliation":5,"role":22},"Elisabetta Munzone, MD","PRINCIPAL_INVESTIGATOR",[24,28],{"name":21,"role":25,"phone":26,"phoneExt":10,"email":27},"CONTACT","+39 0257489405","elisabetta.munzone@ieo.it",{"name":29,"role":25,"phone":30,"phoneExt":10,"email":31},"Davide Merli, PHD","+39 0294372213","davide.merli@ieo.it",[33],{"facility":34,"status":35,"city":36,"state":10,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"European Institute of Oncolgy","RECRUITING","Milan","20141","Italy","IT",{"type":41,"coordinates":42},"Point",[43,44],9.18951,45.46427,{"lat":44,"lon":43},[47],{"name":21,"role":25,"phone":10,"phoneExt":10,"email":10},{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100596719","toxicity-markers-to-trastuzumab-deruxtecan-t-dxd-in-patients-with-advanced-breast-cancer-100596719",false,"NCT07049133","Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer","Identification Of Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer. Tox-DXd: a Prospective, Observational Study","Tox-DXd","Inclusion Criteria:\n\n* Male or female, aged at least 18 years.\n* Histologically documented invasive breast cancer, either HER2-positive or HER2-low\u002Fultralow.\n* Candidate to receive T-DXd as per standard practice.\n* Consent for the provision of blood samples for exploratory analyses.\n\nExclusion Criteria:\n\n* Operable, non-metastatic breast cancer\n* Unwillingness to provide additional blood draws","ALL","18 Years",{"count":61,"type":62},84,"ESTIMATED","OBSERVATIONAL","the anti-Human Epidermal Growth Factor Receptor 2 (HER2) Trastuzumab-Deruxtecan (T-DXd) has shown impressive clinical activity in pretreated patients with metastatic breast cancer (MBC) but is also associated with a non-negligible rate of adverse events that may lead to treatment discontinuation and\u002For the onset of pneumonitis\u002Finterstitial lung disease (ILD)\n\nThe aim of the study is to identify and describe potentially predictive markers related to the onset of relevant T-DXd-related toxicities",[66],"Metastatic Breast Cancer",[66,68,69],"Trastuzumab-Deruxtecan","ILD\u002Fpulmonitis","2026-01-02",{"date":72,"type":73},"2026-01-06","ACTUAL",{"date":75,"type":73},"2025-07-31",{"date":77,"type":62},"2027-12-31",{"name":5,"class":6},1]