[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552252":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":56,"collaborators":21,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":21,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":21,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":21,"overallStatus":79,"whyStopped":21,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Fudan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-A1921+Adebrelimab","EXPERIMENTAL","Via intravenous infusion",[13,14],"Drug: SHR-A1921","Drug: Adebrelimab",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","SHR-A1921","Anti-TROP-2 ADC",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Adebrelimab","PD-L1 inhibitor",[9],[27],{"name":28,"affiliation":29,"role":30},"Hongxia Wang","Fudan Cancer Hospital","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":21,"email":35},"CONTACT","+8621-38196379","whx365@126.com",{"name":37,"role":33,"phone":38,"phoneExt":21,"email":39},"Zhonghua Tao","+86-13774315805","drtaozhh@126.com",[41],{"facility":29,"status":21,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Shanghai","Shanghai Municipality","200230","China","CN",{"type":48,"coordinates":49},"Point",[50,51],121.45806,31.22222,{"lat":51,"lon":50},[54,55],{"name":28,"role":33,"phone":34,"phoneExt":21,"email":35},{"name":37,"role":33,"phone":38,"phoneExt":21,"email":39},{"type":30,"investigatorFullName":28,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Chief Physician","100552252","phase-2-study-of-shr-a1921-combined-adebrelimab-in-hr-positive-her2-negative-advanced-breast-cancer-100552252",false,"NCT06470672","Study of SHR-A1921 Combined Adebrelimab in HR-positive, HER2-negative Advanced Breast Cancer","A Phase 2 Study of SHR-A1921 Combined Adebrelimab in Endocrine Therapy-failed HR-positive, HER2-negative Advanced Breast Cancer","Inclusion Criteria:\n\n* 18 years to 75 years old, female patients with breast cancer;\n* ECOG PS Score: 0\\~1;\n* Histologically or cytologically confirmed HR-positive, HER2-negative advanced or metastatic breast cancer;\n* PD-L1 positive;\n* Disease progression after at least prior 2 lines of endocrine therapy, and unable to benefit from further endocrine therapy determined by investigator, of which at least one line of CDK4\u002F6 inhibitor-based treatment; if recurrence or metastasis within 2 years after completion of adjuvant endocrine therapy, marked as first-line treatment;\n* Prior at least 1 line of systemic chemotherapy in recurrent or metastatic setting;\n* Based on RECIST v1.1, at least one measurable lesion;\n* Patients must have a life expectancy ≥ 3 months;\n* Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);\n* Women of childbearing potential (WOCBP) should agree to use an effective method of contraception and no lactation from the initiation of screening to 7 months after the last dose of study therapy; WOCBP should have a negative serum pregnancy result within 7 days before the first dose of study therapy;\n* Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.\n\nExclusion Criteria:\n\n* Has leptomeningeal metastasis confirmed by MRI or lumbar puncture;\n* Has CNS metastasis confirmed by radiology, except following conditions: ①asymptomatic brain metastasis that is not required to radiotherapy or surgery immediately; ②prior local therapy (e.g. radiotherapy or surgery) for brain or dural metastasis, of which stable disease lasting at least 4 weeks confirmed by radiography, and symptomatic therapy (e.g. hormone, mannitol, bevacizumab) has been stopped beyond 2 weeks with no clinical symptom;\n* Prior anti-TROP-2 treatment;\n* Has received or been receiving PD-(L)1 inhibitors and\u002For ADC containing a topoisomerase inhibitor-like payload;\n* Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) that is not well controlled by effective methods, e.g. drainage;\n* Has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy or immunological therapy within 4 weeks before first dose of study therapy; has received antitumor endocrine therapy within one week before first dose of study therapy;\n* Use of other antitumor systemic treatment during the study;\n* Has active autoimmune disease or a history of autoimmune disease;\n* Known history of immunodeficiency, including HIV-positive, other acquired or innate immunodeficient disease, or known history of organ transplantation;\n* Has active hepatitis B (HBsAg-positive and HBV DNA≥500 IU\u002FmL), hepatitis C (positive for HCV antibody and HCV RNA above ULN) and hepatic cirrhosis;\n* Has an active infection requiring antibiotics, antiviral or antifungal treatment, or pyrexia \\>38.5℃ of unknown origin during the screening period before first dose of study therapy (patients with pyrexia due to cancer could be enrolled determined by investigator);\n* Receiving immunosuppressive medication, or systemic corticosteroid therapy for the purpose of immunosuppression (prednisone at \\>10mg\u002Fd or equivalent dose of other corticosteroids), and continuous use within 2 weeks before the first dose of study therapy;\n* Other malignancy within prior 5 years unless curatively treated with no evidence of disease for at least recent 3 years, except: curatively treated in situ cancer of the cervix, skin basal cell carcinoma or skin squamous cell carcinoma;\n* Hypersensitivity to study therapy or any of its excipients;\n* Has known clinically significant lung disease, including but not limited to: interstitial lung disease, pneumonitis, pulmonary fibrosis;\n* Known history of uncontrolled cardiovascular clinical symptom or disease that is not well controlled;\n* Has received a live vaccine within 4 weeks before first dose of study therapy, or potential to receive a live vaccine during the trial treatment;\n* Other conditions that might influence the study and analysis of results in the opinion of the investigator.","FEMALE","18 Years","75 Years",{"count":69,"type":70},32,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","Our study is aimed to evaluate the efficacy and safety of novel ADC named SHR-A1921 combined with Adebrelimab in endocrine therapy-failed HR (Hormone Receptor)-positive, HER2-negative advanced breast cancer.",[76,77,78],"Advanced Breast Cancer","Hormone-receptor-positive Breast Cancer","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","NOT_YET_RECRUITING","2024-12-17",{"date":82,"type":83},"2024-12-20","ACTUAL",{"date":85,"type":70},"2024-12",{"date":87,"type":70},"2026-07",{"name":5,"class":6},1]