[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634503":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":33,"centralContacts":37,"locations":44,"responsibleParty":62,"collaborators":28,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":28,"enrollmentInfo":74,"targetDuration":28,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":28,"overallStatus":46,"whyStopped":28,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Henan Cancer Hospital","OTHER_GOV",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A","EXPERIMENTAL","Cohort A: triple-negative breast cancer (TNBC) previously treated with immune-checkpoint inhibitors (ICI);",[13,14],"Drug: Toripalimab","Drug: TPC",{"label":16,"type":10,"description":17,"interventionNames":18},"Cohort B","Cohort B: TNBC without prior ICI exposure;",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Cohort C","Cohort C: HR-positive\u002FHER2-negative breast cancer.",[13,14],[24,29],{"type":25,"name":26,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Toripalimab",[9,16,20],null,{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"TPC","Treatment of Physician's Choice",[9,16,20],[34],{"name":35,"affiliation":5,"role":36},"Min Yan, Chief physician","PRINCIPAL_INVESTIGATOR",[38,42],{"name":35,"role":39,"phone":40,"phoneExt":28,"email":41},"CONTACT","+86-15713857388","ym200678@126.com",{"name":43,"role":39,"phone":28,"phoneExt":28,"email":28},"Meng wei Zhang, Associate Chief Physician",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Zhengzhou","Henan","450003","China","CN",{"type":53,"coordinates":54},"Point",[55,56],113.64861,34.75778,{"lat":56,"lon":55},[59,60,61],{"name":35,"role":39,"phone":40,"phoneExt":28,"email":41},{"name":43,"role":39,"phone":28,"phoneExt":28,"email":28},{"name":35,"role":36,"phone":28,"phoneExt":28,"email":28},{"type":36,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Min Yan, MD","Chief physician","100634503","phase-2-a-multicohort-study-of-toripalimab-in-combination-with-investigator-selected-chemotherapy-for-advanced-her2-negative-breast-cancer-100634503",false,"NCT07540533","A Multicohort Study of Toripalimab in Combination With Investigator-Selected Chemotherapy for Advanced HER2-Negative Breast Cancer","2025-370","Inclusion Criteria:\n\n1. Voluntary participation: the subject must give written informed consent, be compliant, and agree to attend all follow-up visits.\n2. Age ≥ 18 years.\n3. ECOG performance-status score ≤ 1 and life expectancy ≥ 3 months.\n4. Histologically or cytologically confirmed HER2-negative breast cancer (HER2-negative is defined as either IHC 0, IHC 1+, or IHC 2+ with a negative in-situ-hybridisation \\[ISH\\] result).\n5. For subjects with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC):\n\n   \\- Must have experienced progression during\u002Fafter at least one prior systemic regimen for recurrent\u002Fmetastatic disease (recurrence ≤ 12 months after neoadjuvant\u002Fadjuvant therapy counts as first-line failure).\n\n   \\- Cohort assignment by prior immune-checkpoint-inhibitor (ICI) exposure:\n   1. Cohort A - ICI-pretreated:\n\n      * If ICI was given in adjuvant setting, recurrence must occur ≥ 12 months after completion of immunotherapy.\n      * If ICI was given in neoadjuvant or metastatic setting, best overall response must have met clinical-benefit criteria (PR, CR, or SD \\> 24 weeks).\n   2. Cohort B - ICI-naïve: no prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or any other antibody targeting T-cell co-stimulatory or checkpoint pathways.\n6. For subjects with hormone-receptor-positive (HR+) breast cancer:\n\n   * Must have progressed after ≥ 2 prior endocrine regimens in the recurrent\u002Fmetastatic setting (unless investigator judges no endocrine benefit), and\n   * Must have progressed after ≥ 1 prior systemic chemotherapy for recurrent\u002Fmetastatic disease (recurrence ≤ 12 months after adjuvant\u002Fneoadjuvant therapy counts as first-line failure).\n7. At least one measurable lesion per RECIST v1.1.\n8. Adequate organ function, defined as:\n\n   Haematology (no transfusion within 14 days):\n   1. Haemoglobin ≥ 9 g\u002FdL\n   2. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n   3. Platelet count ≥ 100 × 10⁹\u002FL . Serum chemistry:\n\n   \u003C!-- -->\n\n   1. Total bilirubin ≤ 1.5 × ULN, or if total bilirubin \\> ULN then direct bilirubin ≤ ULN\n   2. ALT and AST ≤ 2.5 × ULN\n   3. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL\u002Fmin\n9. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 7 days before first dose and must use highly effective contraception from first dose until 6 months after last dose.\n\nWOCBP is defined as any sexually mature female who has not undergone hysterectomy or bilateral oophorectomy and who has not experienced natural amenorrhoea for ≥ 24 consecutive months (including women with treatment-induced amenorrhoea).Men whose partners are WOCBP must also use effective contraception during the same period.\n\nExclusion Criteria:\n\n1. Uncontrolled central-nervous-system metastases (symptomatic or requiring corticosteroids or mannitol for symptom control).\n2. Clinically significant or uncontrolled cardiac disease within 6 months before first dose, including congestive heart failure, angina, myocardial infarction, or ventricular arrhythmia.\n3. Malignancy within 5 years before first dose, except adequately treated basal-cell carcinoma of the skin or carcinoma in situ of the cervix.\n4. Active autoimmune disease requiring systemic therapy within 2 years before first dose, except vitiligo, type-1 diabetes, or residual hypothyroidism due to autoimmune thyroiditis managed with hormone replacement only.\n5. Uncontrolled pleural, pericardial, or ascitic fluid requiring repeated drainage.\n6. Documented human immunodeficiency virus (HIV) infection.\n7. Documented hepatitis-B infection or active hepatitis-C infection.\n8. Prior hypersensitivity to any component or excipient of the investigational product(s).\n9. Any condition judged by the investigator to render the patient unsuitable for trial participation.","ALL","18 Years",{"count":75,"type":76},92,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","To evaluate the efficacy and safety of toripalimab in combination with investigator-selected chemotherapy in patients with recurrent or metastatic HER2-negative breast cancer who have failed prior systemic therapy.",[82],"Advanced Breast Cancer","2026-04-14",{"date":85,"type":86},"2026-04-20","ACTUAL",{"date":88,"type":86},"2026-01-20",{"date":90,"type":76},"2028-08",{"name":5,"class":6},1]