[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503178":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":30,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":30,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":30,"enrollmentInfo":60,"targetDuration":30,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":30,"overallStatus":35,"whyStopped":30,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"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,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Renji Hospital, School of Medicine, Shanghai Jiaotong University","RECRUITING","Shanghai","200127","China","CN",{"type":41,"coordinates":42},"Point",[43,44],121.45806,31.22222,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":29,"phoneExt":30,"email":31},"Wenjin Yin",{"type":25,"investigatorFullName":48,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Deputy Chief of Breast Surgery Department","100503178","rc48-adc-in-her2-low-advanced-breast-cancer-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":61,"type":62},36,"ESTIMATED","INTERVENTIONAL",[65],"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.",[68],"Advanced Breast Cancer","2026-05-10",{"date":71,"type":72},"2026-05-13","ACTUAL",{"date":74,"type":72},"2023-05-04",{"date":76,"type":62},"2027-12",{"name":5,"class":6},1]