[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhenzhen Liu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100608216","primary-prevention-of-thrombocytopenia-associated-with-t-dm1-therapy-in-her2-positive-breast-cancer-with-herombopag-100608216",false,"NCT07198672","Primary Prevention of Thrombocytopenia Associated With T-DM1 Therapy in HER2 Positive Breast Cancer With Herombopag","A Multicenter, Single-arm, Exploratory Clinical Study of Herombopag Olamine Tablets for the Primary Prevention of Treatment-related Thrombocytopenia in HER2-positive Breast Cancer Patients Receiving T-DM1 Therapy","Inclusion Criteria:\n\n1. Female, age ≥18 years;\n2. Histopathologically or cytologically confirmed diagnosis of breast cancer;\n3. Tumor tissue confirmed as HER2-positive, defined as immunohistochemistry (IHC) showing +++, or IHC++ with fluorescence in situ hybridization (FISH) demonstrating HER2-positive status;\n4. Planned to receive T-DM1 regimen based on clinical judgment;\n5. ECOG PS score: 0-2;\n6. Expected survival greater than 12 weeks;\n7. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. A confirmed history of severe allergic reactions to the active ingredients or excipients of the therapeutic drug;\n2. Presence of other underlying diseases or comorbidities causing thrombocytopenia, such as aplastic anemia, immune thrombocytopenia, myelodysplastic syndrome, etc.;\n3. Individuals with hereditary bleeding disorders, coagulation dysfunction, high bleeding risk, or a history of thrombotic events (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction, pulmonary embolism) within 6 months prior to initial medication use;\n4. Individuals with uncontrolled hypertension and a history of hypertensive crisis or hypertensive encephalopathy;\n5. Pregnant or lactating women;\n6. Presence of multiple factors affecting oral drug absorption, such as dysphagia, nausea\u002Fvomiting, chronic diarrhea, or intestinal obstruction;\n7. History of severe psychiatric disorders, substance abuse, alcoholism, or drug addiction;\n8. Currently participating in interventional clinical research treatment, or having received other investigational drugs or devices within 4 weeks prior to first dosing (individuals who failed screening for other clinical trials may be included in this study);\n9. Any other factors deemed by the investigator to increase study risk, affect patient compliance with the protocol, or impact the patient's ability to complete the trial, such as physiological or psychological conditions that make participation in this study inappropriate;","ALL","18 Years",{"count":19,"type":20},45,"ESTIMATED","INTERVENTIONAL",[23],"NA","Ado-trastuzumab emtansine (T-DM1) demonstrates favorable efficacy in breast cancer treatment but is frequently associated with thrombocytopenia. Multiple studies indicate that Asian populations face a higher risk of developing thrombocytopenia during T-DM1 therapy, with incidence rates ranging from 52.5% to 69.8% and ≥Grade 3 rates between 29.8% and 45.0%. Severe thrombocytopenia not only increases bleeding risks but may also necessitate T-DM1 dose delays or reductions, thereby compromising treatment efficacy and diminishing patient survival and quality of life. Herombopag selectively binds to the transmembrane region of TPO-R, activating TPO-R-dependent STAT and MAPK signaling pathways. This effectively stimulates megakaryocyte proliferation and differentiation, promoting thrombopoiesis. However, high-level evidence supporting the use of Herombopag for primary prevention of T-DM1-induced thrombocytopenia in breast cancer remains lacking.",[26],"HER2-positive Breast Cancer","NOT_YET_RECRUITING","2025-09-22",{"date":30,"type":31},"2025-09-30","ACTUAL",{"date":33,"type":20},"2025-10-31",{"date":35,"type":20},"2028-10-31",{"name":37,"class":38},"Zhenzhen Liu","OTHER_GOV",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":46,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100475803","phase-2-clinical-study-of-camrelizumab-combined-with-tcb-versus-tcb-in-neoadjuvant-treatment-of-triple-negative-breast-cancer-100475803","NCT05475678","Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer","A Randomized, Open Label, Parallel Controlled, Multicenter Phase II Clinical Study of Carelizumab Combined With TCb (Docetaxel+Carboplatin) Versus TCb Neoadjuvant Therapy for Triple Negative Breast Cancer","Inclusion Criteria:\n\n1. Age: 18-70 years old\n2. cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；\n3. Pathologically proven triple negative breast cancer:\n\n   Triple-negative breast cancer is defined as:\n   * Negative for ER and PR (IHC nuclear staining \\\u003C10%)\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.","FEMALE","70 Years",{"count":49,"type":20},369,[51],"PHASE2","Triple-negative breast cancer (TNBC) is a special subtype of breast cancer that lacks the expression of ER, PR, and Her-2 proteins, accounting for 15%-20% of all breast cancers.TNBC patients do not benefit from endocrine therapy or HER-2-targeted therapy, but are sensitive to cytotoxic drug therapy.Although the survival of TNBC patients has improved significantly compared with the past, it is still the type with the worst prognosis among all subtypes of breast cancer. Methods and drugs to further improve the therapeutic effect of TNBC patients are still being explored.\n\nCamrelizumab, a PD-1 inhibitor produced by Hengrui, has been approved for the treatment of various malignant tumors including advanced lung cancer, advanced liver cancer and advanced esophageal cancer. Shows good therapeutic effect and safety.\n\nTherefore, this study intends to explore the superiority of camrelizumab on the basis of the less toxic anthracycline-free TCb regimen.In order to provide more effective and safe neoadjuvant therapy for lymph node-positive TNBC patients.",[54,55,56],"Breast Cancer","Triple Negative Breast Cancer","Camrelizumab",[55,56,58,59,60],"Neoadjuvant chemotherapy","Pathological complete response rate","Disease-free survival","RECRUITING","2025-01-21",{"date":64,"type":31},"2025-01-23",{"date":66,"type":31},"2022-12-20",{"date":68,"type":20},"2029-12-31",{"name":37,"class":38},1,""]