[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612698":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":11,"centralContacts":34,"locations":11,"responsibleParty":40,"collaborators":11,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":11,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":11,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":11},{"fullName":5,"class":6},"Henan Cancer Hospital","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"PCb-EC+PD1","ACTIVE_COMPARATOR",null,[13,14],"Drug: Toripalimab","Drug: PCb-EC",{"label":16,"type":17,"description":11,"interventionNames":18},"PCb+PD1","EXPERIMENTAL",[13,19],"Drug: PCb",[21,26,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DRUG","Toripalimab","Toripalimab 240mg every cycle",[16,9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"PCb-EC","Albumin Paclitaxel + Carboplatin\\*4 Followed by Epirubicin + Cyclophosphamide\\*4",[9],{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":11},"PCb","Albumin Paclitaxel + Carboplatin \\*6",[16],[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Zhenzhen Liu","CONTACT","+8613603862755","zlyyliuzhenzhen0800@zzu.edu.cn",{"type":41,"investigatorFullName":36,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Professor","100612698","phase-2-toripalimab-combined-with-anthracycline-free-or-anthracycline-containing-chemotherapy-as-neoadjuvant-chemotherapy-for-early-triple-negative-breast-cancer-100612698",false,"NCT07256964","Toripalimab Combined With Anthracycline-free or Anthracycline-containing Chemotherapy as Neoadjuvant Chemotherapy for Early Triple Negative Breast Cancer","A Prospective, Randomized Controlled, Multicenter Phase II Clinical Study of Toripalimab Combined With PCb-EC Regimen (Albumin Paclitaxel + Carboplatin Followed by Epirubicin + Cyclophosphamide) or PCb Regimen (Albumin Paclitaxel + Carboplatin) as Neoadjuvant Therapy for Triple-Negative Breast Cancer","Inclusion Criteria:\n\n1. Age: 18-70 years.\n2. Disease Status: Clinical pathological confirmation of cT2-cT4d, or cT1c with axillary lymph node metastasis.\n3. Pathology: Histopathologically confirmed triple-negative, invasive breast carcinoma.\n4. Definition of Triple-Negative Breast Cancer:\n5. ER and PR negative (IHC nuclear staining \\\u003C10%).\n6. Her-2 negative (IHC 0 or 1+ without FISH, or IHC 2+ with FISH demonstrating no amplification).\n7. Measurable Disease: Presence of clinically measurable lesion(s) confirmed by ultrasound, mammography, or optional MRI within 1 month prior to randomization.\n8. Adequate Organ and Bone Marrow Function (within 1 month prior to chemotherapy), indicating no contraindications for chemotherapy:\n9. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL\n10. Hemoglobin (Hb) ≥ 90 g\u002FL\n11. Platelet count (PLT) ≥ 100 × 10⁹\u002FL\n12. Total Bilirubin (TBIL) \\\u003C 1.5 × ULN (Upper Limit of Normal)\n13. Serum Creatinine (Cr) \\\u003C 1.5 × ULN\n14. Aspartate Aminotransferase (AST) \u002F Alanine Aminotransferase (ALT) \\\u003C 1.5 × ULN\n15. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 50% as measured by echocardiogram.\n16. Pregnancy Status: For women of childbearing potential, a negative serum pregnancy test within 14 days prior to randomization.\n17. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1.\n18. Informed Consent: Signed informed consent obtained.\n\nExclusion Criteria:\n\n1. Metastatic Disease: Evidence of metastatic breast cancer. (To exclude metastasis, CT scans of the chest and abdomen, and a bone scan must be performed at any time point from diagnosis to randomization; PET\u002FCT may serve as an alternative imaging modality).\n2. Prior Anti-Cancer Therapy: Any prior chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for the current breast cancer.\n3. Second Primary Malignancy: Presence of a second primary malignancy, except for:\n4. Adequately treated non-melanoma skin carcinoma.\n5. Prior Immunotherapy: Previous treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or any other immunomodulatory therapy.\n6. Immunodeficiency or Autoimmune Disease: Diagnosed immunodeficiency or active autoimmune disease requiring systemic treatment.\n7. Severe Comorbidities: Severe or uncontrolled pulmonary or cardiac disease.\n8. Active Hepatitis: Active Hepatitis B or Hepatitis C infection.\n9. Transplantation History: History of solid organ or bone marrow transplantation.\n10. Pregnancy\u002FLactation: Pregnant or lactating women.\n11. Other Medical Conditions: Any other severe, uncontrolled medical condition that, in the investigator's judgment, constitutes a contraindication to chemotherapy.","ALL","18 Years","70 Years",{"count":54,"type":55},216,"ESTIMATED","INTERVENTIONAL",[58],"PHASE2","This study aims to evaluate the efficacy and safety of a PD-1 inhibitor combined with different chemotherapy regimens (PCb-EC and PCb), in order to develop a superior and well-tolerated neoadjuvant therapeutic strategy for patients with triple-negative breast cancer.",[61],"TNBC - Triple-Negative Breast Cancer",[63,64,65],"PD1","TNBC","Neoadjuvant chemotherapy","NOT_YET_RECRUITING","2025-11-27",{"date":69,"type":70},"2025-12-02","ACTUAL",{"date":72,"type":55},"2025-11-26",{"date":74,"type":55},"2033-12-31",{"name":5,"class":6}]