[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582224":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":65,"collaborators":31,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":31,"eligibilityCriteria":74,"healthyVolunteers":71,"sex":75,"minAge":76,"maxAge":31,"enrollmentInfo":77,"targetDuration":31,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":31,"overallStatus":49,"whyStopped":31,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Henan Cancer Hospital","OTHER_GOV",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Treatment group1","EXPERIMENTAL","NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 3）",[13,14,15],"Drug: Serplulimab","Drug: Epirubicin","Drug: Albumin Paclitaxel",{"label":17,"type":10,"description":18,"interventionNames":19},"Experimental: Treatment group2","NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 1）",[13,14,15],{"label":21,"type":22,"description":23,"interventionNames":24},"Control group","ACTIVE_COMPARATOR","NabPE(Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1）",[14,15],[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Serplulimab","Serplulimab is administered intravenously",[9,17],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Epirubicin","Epirubicin ivgtt",[21,9,17],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Albumin Paclitaxel","Albumin Paclitaxel ivgtt",[21,9,17],[41],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Zhenzhen Liu, Dr.","CONTACT","13603862755","liuzhenzhen73@126.com",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Henan cancer hospital","RECRUITING","Zhengzhou","Henan","450000","China","CN",{"type":56,"coordinates":57},"Point",[58,59],113.64861,34.75778,{"lat":59,"lon":58},[62],{"name":63,"role":43,"phone":44,"phoneExt":31,"email":64},"Zhenzhen Liu, PHD","zlyyliuzhenzhen0800@zzu.edu.cn",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Zhenzhen Liu","Professor","100582224","phase-2-serplulimab-combined-with-chemotherapy-for-early-stage-hrher2--breast-cancer-100582224",false,"NCT06860529","Serplulimab Combined With Chemotherapy for Early-stage HR+\u002FHER2- Breast Cancer","3.1 Inclusion Criteria\n\nPatients must meet all of the following criteria to be eligible:\n\nAge: ≥18 years old.\n\nClinical-pathological confirmation:\n\ncT2-cT4 breast cancer, or cT1c with axillary lymph node metastasis.\n\nHistopathologically confirmed HR+\u002FHER2- invasive breast cancer:\n\nER and\u002For PR positive (IHC nuclear staining ≥1%).\n\nHER2-negative (IHC 0 or 1+ without FISH testing, or IHC 2+ with FISH-negative amplification).\n\nKi67 ≥20%.\n\nClinically measurable lesions:\n\nMeasurable lesions confirmed by ultrasound, mammography, or MRI (optional) within 1 month prior to randomization.\n\nAdequate organ and bone marrow function (within 1 month prior to chemotherapy):\n\nAbsolute neutrophil count (ANC) ≥2.0 × 10\\^9\u002FL.\n\nHemoglobin ≥90 g\u002FL.\n\nPlatelet count ≥100 × 10\\^9\u002FL.\n\nTotal bilirubin \\\u003C1.5 × ULN (upper limit of normal).\n\nCreatinine \\\u003C1.5 × ULN.\n\nAST\u002FALT \\\u003C1.5 × ULN.\n\nCardiac function: Left ventricular ejection fraction (LVEF) ≥55% by echocardiography.\n\nReproductive status: Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization.\n\nECOG performance status: ≤1.\n\nInformed consent: Signed written informed consent.\n\n3.2 Exclusion Criteria\n\nPatients meeting any of the following criteria will be excluded:\n\nEvidence of metastatic breast cancer:\n\nChest\u002Fabdominal CT and bone scan required at any time from diagnosis to randomization to exclude metastasis.\n\nPET\u002FCT may substitute for other imaging modalities.\n\nPrior systemic therapy: Chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for the current breast cancer.\n\nSecond primary malignancy, except:\n\nAdequately treated non-melanoma skin cancer.\n\nPrior immunotherapy: Treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint inhibitors.\n\nImmune-related conditions:\n\nDiagnosed immunodeficiency or active autoimmune disease.\n\nSevere cardiopulmonary disease: Uncontrolled or clinically significant.\n\nActive hepatitis: Hepatitis B or C with detectable viral load.\n\nTransplant history: Prior organ or bone marrow transplantation.\n\nPregnancy or lactation: Pregnant or breastfeeding women.\n\nOther contraindications: Severe uncontrolled comorbidities deemed by investigators to contraindicate chemotherapy or PD-1 inhibitor therapy.","ALL","18 Years",{"count":78,"type":79},357,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","The neoadjuvant treatment options commonly used for HR+\u002FHER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice.\n\nThe aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HR+\u002FHER2- breast cancer",[85],"HR+\u002FHER2- Breast Cancer","2025-06-20",{"date":88,"type":89},"2025-06-23","ACTUAL",{"date":91,"type":89},"2025-04-15",{"date":93,"type":79},"2030-03-31",{"name":5,"class":6},1]