[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549407":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":38,"centralContacts":42,"locations":47,"responsibleParty":64,"collaborators":11,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":11,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":11,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":11,"overallStatus":49,"whyStopped":11,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Beijing GoBroad Hospital","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-A1811+adebrelimab","EXPERIMENTAL",null,[13,14],"Drug: SHR-A1811","Drug: Adebrelimab",{"label":16,"type":10,"description":11,"interventionNames":17},"SHR-A1921+adebrelimab",[18,14],"Drug: SHR-A1921",{"label":20,"type":10,"description":11,"interventionNames":21},"SHR-A2102 + adebrelimab",[14,22],"Drug: SHR-A2102",[24,29,32,35],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"DRUG","SHR-A1811","Via intravenous infusion",[9],{"type":25,"name":30,"description":27,"armGroupLabels":31,"otherNames":11},"SHR-A1921",[16],{"type":25,"name":33,"description":27,"armGroupLabels":34,"otherNames":11},"Adebrelimab",[9,16,20],{"type":25,"name":36,"description":27,"armGroupLabels":37,"otherNames":11},"SHR-A2102",[20],[39],{"name":40,"affiliation":5,"role":41},"Wei Zhao","PRINCIPAL_INVESTIGATOR",[43],{"name":40,"role":44,"phone":45,"phoneExt":11,"email":46},"CONTACT","+8610-50847588","Zhaow6@gobroadhealthcare.com",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Beijing","Beijing Municipality","102200","China","CN",{"type":56,"coordinates":57},"Point",[58,59],116.39723,39.9075,{"lat":59,"lon":58},[62,63],{"name":40,"role":44,"phone":45,"phoneExt":11,"email":46},{"name":40,"role":41,"phone":11,"phoneExt":11,"email":11},{"type":41,"investigatorFullName":40,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Attending physician","100549407","phase-2-study-of-adcs-combined-with-adebrelimab-in-her2-negative-advanced-breast-cancer-100549407",false,"NCT06433609","Study of ADCs Combined With Adebrelimab in HER2-negative Advanced Breast Cancer","A Phase II Study of Antibody-Drug Conjugates (ADCs) Combined With Adebrelimab in HER2-negative Advanced Breast Cancer","Inclusion Criteria:\n\n1. 18 years to 75 years old (including boundary values);\n2. ECOG PS Score: 0\\~1;\n3. Histologically or cytologically confirmed HER2-negative advanced breast cancer;\n4. Disease progression after prior ≥1 line of systemic therapy; if HR-positive, prior CDK4\u002F6 inhibitor is necessary;\n5. Based on RECIST v1.1, at least one measurable lesion;\n6. Brain metastasis with no clinical symptoms, or treated, stable brain metastases are eligible;\n7. Patients must have a life expectancy ≥ 6 months;\n8. Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);\n9. Women of childbearing potential should have a negative urine or serum pregnancy, and must promise to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy or be celibate; Men who are not surgically sterile (including those sterilized by methods other than bilateral orchiectomy \\[e.g., vasectomy\\]) and who intend to have sexual intercourse with female partners of childbearing potential must use a contraceptive method from enrollment, throughout the study, and for 6 months after the end of the study to prevent partner pregnancy;\n10. Available blood samples for ctDNA detection in the exploratory study;\n11. Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.\n\nExclusion Criteria:\n\n1. Has known active brain metastasis which needs local therapy immediately;\n2. Prior use of ADCs with the same target as study drugs;\n3. Existence of third space fluid that is not well controlled by effective methods, e.g. drainage;\n4. 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;\n5. Use of other antitumor systemic treatment during the study;\n6. Has active autoimmune disease or a history of autoimmune disease;\n7. Known history of immunodeficiency, including HIV-positive, other acquired or innate immunodeficient disease, or known history of organ transplantation;\n8. 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;\n9. 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);\n10. 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;\n11. 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;\n12. Hypersensitivity to study therapy or any of its excipients;\n13. Has known clinically significant lung disease, including but not limited to: interstitial lung disease, pneumonitis, pulmonary fibrosis;\n14. Known history of uncontrolled cardiovascular clinical symptom or disease that is not well controlled;\n15. 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;\n16. Women with a positive serum or urine pregnancy test or who are breastfeeding; patients of childbearing potential who are unwilling or not available to use an effective method of contraception;\n17. Other conditions that might influence the study and analysis of results in the opinion of the investigator.","ALL","18 Years","75 Years",{"count":77,"type":78},113,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","Our study is aimed to evaluate the efficacy and safety of novel ADCs named SHR-A1811, SHR-A1921 and SHR-A2102 combined with adebrelimab in HER2-negative advanced breast cancer.",[84],"Advanced Breast Cancer","2026-07-13",{"date":87,"type":88},"2026-07-14","ACTUAL",{"date":90,"type":88},"2024-08-05",{"date":92,"type":78},"2027-11",{"name":5,"class":6},1]