[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576129":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":27,"locations":33,"responsibleParty":46,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":10,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":10,"enrollmentInfo":59,"targetDuration":10,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Henan Cancer Hospital","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"NabPE+Serplulimab group",null,"Epirubicin 75mg\u002Fm2 ivgtt on Day 1+Albumin Paclitaxel 260mg\u002Fm2 ivgtt on Day 1+Serplulimab 4.5mg\u002FKg ivgtt on Day 3, every 3 weeks for 6 cycles.",[13,14],"Drug: Serplulimab","Drug: NabPE",{"label":16,"type":10,"description":17,"interventionNames":18},"NabPE","Epirubicin 75mg\u002Fm2 ivgtt on Day 1+Albumin Paclitaxel 260mg\u002Fm2 ivgtt on Day 1, every 3 weeks for 6 cycles.",[14],[20,24],{"type":21,"name":22,"description":22,"armGroupLabels":23,"otherNames":10},"DRUG","Serplulimab",[9],{"type":21,"name":16,"description":25,"armGroupLabels":26,"otherNames":10},"Epirubicin 75mg\u002Fm2 ivgtt +Albumin Paclitaxel 260mg\u002Fm2",[16,9],[28],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Zhenzhen Liu, Dr.","CONTACT","13603862755","zlyyliuzhenzhen0800@zzu.edu.cn",[34],{"facility":35,"status":36,"city":37,"state":10,"zip":10,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":10},"Henan cancer hospital","RECRUITING","Zhengzhou","China","CN",{"type":41,"coordinates":42},"Point",[43,44],113.64861,34.75778,{"lat":44,"lon":43},{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Zhenzhen Liu","Professor","100576129","nabpe-with-or-without-serplulimab-for-early-stage-hrher2--breast-cancer-100576129",false,"NCT06781281","NabPE With or Without Serplulimab for Early-stage HR+\u002FHER2- Breast Cancer.","Neoadjuvant NabPE With or Without Serplulimab for Early-stage Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+\u002FHER2-) Breast cancer-an Observational Real-world Study.","Inclusion Criteria:\n\n1. Age\\>=18 years old\n2. cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；\n3. Pathologically proven HR+\u002FHER2- breast cancer:\n\n   defined as:\n   * positive for ER or PR (IHC nuclear staining \\>1%)\n   * Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by FISH)；\n4. Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；\n5. Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；\n6. Cardiac ultrasound EF value ≧55%；\n7. Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;\n8. ECOG score≤1 point;\n9. Sign informed consent；\n\nExclusion Criteria:\n\n1. The patient has evidence of metastatic breast cancer；\n2. For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;\n3. The patient has a second primary malignancy other than adequately treated skin cancer;\n4. The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs, or other immunotherapy；\n5. The patient has been diagnosed with immunodeficiency disease or autoimmune disease;\n6. The patient has severe lung or heart disease;\n7. The patient has active hepatitis B and C;\n8. The patient has a history of organ transplantation or bone marrow transplantation;\n9. pregnant or breastfeeding women;\n10. The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.","ALL","18 Years",{"count":60,"type":61},709,"ESTIMATED","OBSERVATIONAL","The goal of this clinical study is to learn if serplulimab is effective in early HR+\u002FHER2- breast cancer. This trial serves a prospective parallel control cohort for HELEN-018 (NCT). The main questions it aims to answer are:\n\nDoes serplulimab combined with neoadjuvant chemotherapy improve the pCR rate of early HR+\u002FHER2- breast cancer? What medical problems do participants have when receiving serplulimab? Researchers will compare the effect of serplulimab combined with chemotherapy to the effect of chemotherapy reported in literature.\n\nParticipants will: Receive serplulimab plus chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is a pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant serplulimab every 3 weeks for up to 6 months from the begining of the treatment.",[65],"Breast Cancer Invasive",[67,68,69],"HR+\u002FHER2-","PD1","Real-world study","2025-06-20",{"date":72,"type":73},"2025-06-23","ACTUAL",{"date":75,"type":73},"2024-12-04",{"date":77,"type":61},"2030-11-28",{"name":5,"class":6},1]