[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503178":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":48,"collaborators":30,"id":50,"slug":30,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":30,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":30,"enrollmentInfo":58,"targetDuration":30,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":30,"overallStatus":35,"whyStopped":30,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"RC48-ADC","EXPERIMENTAL","RC48-ADC as salvage treatment for HER2-low advanced breast cancer",[13],"Drug: Disitamab vedotin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Disitamab vedotin","2.0mg\u002Fkg, iv, day1, every 2 weeks",[9],[9],[22],{"name":23,"affiliation":24,"role":25},"Wenjin Yin, M.D.","Renji Hospital,School of Medicine, Shanghai Jiaotong University","PRINCIPAL_INVESTIGATOR",[27],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","86(21)68385569",null,"yinwenjin@renji.com",[33],{"facility":34,"status":35,"city":36,"state":30,"zip":37,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Renji Hospital, School of Medicine, Shanghai Jiaotong University","RECRUITING","Shanghai","200127","China",{"type":40,"coordinates":41},"Point",[42,43],121.45806,31.22222,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":29,"phoneExt":30,"email":31},"Wenjin Yin",{"type":25,"investigatorFullName":47,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Deputy Chief of Breast Surgery Department","100503178",false,"NCT05831878","RC48-ADC in HER2-low Advanced Breast Cancer","Disitamab Vedotin (RC48-ADC) in Patients With HER2-low Advanced Breast Cancer","Inclusion Criteria:\n\n* Female patients aged ≥18 years\n* Expected survival ≥12 weeks\n* ECOG 0-1\n* Histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable\n* At least one measurable lesion according to the RECIST 1.1\n* No history of antibody-drug conjugate use\n* Up to one previous chemotherapy for advanced disease\n* Available hormone receptor status. Hormone receptor-positive subjects are allowed to receive no more than two previous endocrine therapy for advanced disease\n* HER2-low tumors, defined as IHC1+ or IHC2+ with negative FISH test; or HER2-ultralow tumors, defined as incomplete and faint membrane staining in \\>0 but ≤10% of tumor cells\n* Adequate organ function\n\nExclusion Criteria:\n\n* History of thromboembolic events\n* Uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc.\n* Active infections requiring systemic treatment\n* Pregnant or lactating\n* Presence of brain metastases and\u002For carcinomatous meningitis","FEMALE","18 Years",{"count":59,"type":60},36,"ESTIMATED","INTERVENTIONAL",[63],"NA","To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease without previous use of antibody-drug conjugate.",[66],"Advanced Breast Cancer","2026-05-10",{"date":69,"type":70},"2026-05-13","ACTUAL",{"date":72,"type":70},"2023-05-04",{"date":74,"type":60},"2027-12",{"name":5,"class":6},1]