[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Wang Jiayu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100566345","phase-2-efficacy-and-safety-of-a-two-week-dosing-regimen-of-vinorelbine-combined-with-liposomal-doxorubicin-in-the-treatment-of-her2-negative-advanced-breast-cancer-100566345",false,"NCT06653972","Efficacy and Safety of a Two-week Dosing Regimen of Vinorelbine Combined with Liposomal Doxorubicin in the Treatment of HER2-negative Advanced Breast Cancer","Efficacy and Safety of Liposomal Doxorubicin Combined with Vinorelbine in the Treatment of Advanced Metastatic Breast Cancer: a Single-Center, Prospective Phase II Clinical Study","EASOVCWDITHABC","Inclusion Criteria:\n\n1. Age ≥18 years old，and ≤70 years old.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n3. Expected survival period not less than 12 weeks.\n4. At least 1 measurable lesion according to RECIST 1.1 standard.\n5. Previously received treatment with taxanes and anthracyclines. Note: Taxanes and anthracyclines can be utilized at various treatment stages, including neoadjuvant\u002Fadjuvant，recurrence\u002Fmetastasis, with a treatment duration of at least 2 cycles (e.g., 21 days\u002Fcycle). If disease progression or intolerance occurs during a treatment regimen containing taxanes or anthracyclines, prior usage does not need to meet the above criteria.\n6. Patients with metastatic breast cancer have received ≥2 lines of chemotherapy. Note: The number of chemotherapy lines refers to chemotherapy agents(each regimen counting as one line, excluding endocrine therapies; maintenance therapy does not count toward the line number).\n\n6\\. Immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) validated HER2 negative, including IHC- and IHC 1+\u002F2+ with FISH negative.\n\n7\\. The organ function must meet the following requirements：\n\n1. . Blood Routine\n\n   * ANC≥1.5×109\u002FL；\n   * PLT≥90×109\u002FL；\n   * Hb≥90 g\u002FL；\n2. . Blood Biochemistry\n\n   * TBIL≤1.5×ULN；\n   * ALT and AST≤2×ULN；ALT和AST≤5×ULN for patients with liver metastasis；\n   * BUN and Cr≤1.5×ULN and the Creatinine Clearance Rate ≥50 mL\u002Fmin (Cockcroft-Gault formula calculated)；\n3. . Echocardiogram\n\n   • LVEF≥50%；\n4. . electrocardiogram\n\n   * The QT interval (QTcF) corrected by Fridericia method less than 450 ms for male and less than 470 ms for female.\n\n     8\\. Volunteer to join this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. There is a third interstitial fluid accumulation that cannot be controlled by drainage or other methods (such as a large amount of hydrothorax and ascites).\n2. Symptomatic or uncontrolled brain or meningeal metastases.\n3. Patients with only bone or skin metastasis as the assessable lesion.\n4. Previously suffered from other malignant tumors.\n5. Those who have used vinorelbine or Pegylated Liposomal Doxorubicin during the advanced disease stage.\n6. Individuals with a known history of allergies to the components of the interventions; History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases and a history of organ transplantation.\n7. Any heart disease or other conditions evaluated unsuitable by the researcher.\n8. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or female patients of reproductive age who are unwilling to take effective contraceptive measures throughout the trial period.\n9. According to the investigator\\'s judgment, there are concomitant diseases that seriously endanger the patient\\'s safety or affect the patient\\'s completion of the study (including severe bleeding tendency, history of surgery within 2 weeks, hypertension beyond drug control, serious diabetes, active infection, thyroid disease, etc.).\n10. Having a clear history of neurological or mental disorders, including epilepsy or dementia.\n11. According to the RECIST 1.1 criteria, researchers determined that patients who received the last anti-tumor regimen before enrollment did not experience disease progression.\n12. Immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) validated human epidermal growth factor receptor 2 (HER2) positive.","FEMALE","18 Years","70 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","With advancements in various treatment modalities, the survival of breast cancer patients has continuously improved. Patients with advanced breast cancer who have undergone multiple lines of therapy still have treatment options, but standard treatment protocols are lacking. Anthracyclines are a cornerstone in breast cancer treatment; however, their cumulative dose-related cardiac toxicity limits their use. Liposomal doxorubicin exhibits comparable efficacy to conventional anthracyclines and is not affected by previous cumulative doses. The combination of vinorelbine with liposomal doxorubicin shows reduced cross-toxicity, and several studies have demonstrated the effectiveness of this regimen in metastatic HER2-negative breast cancer patients.\n\nTherefore, we aim to explore whether optimizing the dosage and treatment cycle of this combination therapy can provide a viable treatment option for metastatic HER2-negative breast cancer patients who have previously received second-line or higher chemotherapy, seeking a regimen that balances efficacy and safety.\n\nThis study is a single-center, single-arm Phase II clinical trial planned to enroll 30 metastatic HER2-negative breast cancer patients who have previously undergone second-line or higher chemotherapy. Participants will receive an optimized regimen of liposomal doxorubicin combined with vinorelbine, with safety assessed every cycle and efficacy evaluated every three cycles. Treatment will continue until radiographic evidence indicates disease progression, intolerable toxicity occurs, informed consent is withdrawn, or the investigator decides to discontinue treatment. Following treatment, each participant will undergo survival follow-up every three months until death, loss to follow-up, or withdrawal of consent.",[28,29,30],"Her2-negative Metastatic Breast Cancer","Vinorelbine","Liposomal Doxorubicin","NOT_YET_RECRUITING","2024-10-19",{"date":34,"type":35},"2024-10-23","ACTUAL",{"date":37,"type":22},"2024-11-01",{"date":39,"type":22},"2026-09-30",{"name":41,"class":42},"Wang Jiayu","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100557549","phase-2-efficacy-and-resistant-mechanism-of-eribulin-and-bevacizumab-for-advanced-her2-negative-breast-cancer-100557549","NCT06539559","Efficacy and Resistant Mechanism of Eribulin and Bevacizumab for Advanced HER2 Negative Breast Cancer","Efficacy, Adverse Events and Resistant Mechanism of Eribulin Combined With or Without Bevacizumab for Advanced HER2 Negative Breast Cancer Patients, an Open-label, Randomized, Multi-center PhaseⅡ Clinical Trial.","Inclusion Criteria:\n\n1. Age ≥18 years old，and ≤75 years old.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n3. Expected survival period not less than 12 weeks.\n4. At least 1 measurable lesion according to RECIST 1.1 standard.\n5. previously treated with taxanes and\u002For anthracycline drugs in any stage of breast cancer.\n6. Immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) validated HER2 negative, including IHC- and IHC 1+\u002F2+ with FISH negative.\n7. at least prior 1 line of chemotherapy in the advanced stage.\n8. The organ function must meet the following requirements：\n\n(1). Blood Routine\n\n* ANC≥1.5×109\u002FL；\n* PLT≥90×109\u002FL；\n* Hb≥90 g\u002FL；\n\n  (2). Blood Biochemistry\n* TBIL≤1.5×ULN；\n* ALT and AST≤2×ULN；ALT和AST≤5×ULN for patients with liver metastasis；\n* BUN and Cr≤1.5×ULN and the Creatinine Clearance Rate ≥50 mL\u002Fmin (Cockcroft-Gault formula calculated)；\n\n  (3). Echocardiogram\n* LVEF≥50%；\n\n  (4). electrocardiogram\n* The QT interval (QTcF) corrected by Fridericia method less than 450 ms for male and less than 470 ms for female.\n\n  9\\. Volunteer to join this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. There is a third interstitial fluid accumulation that cannot be controlled by drainage or other methods (such as a large amount of hydrothorax and ascites).\n2. Symptomatic or uncontrolled brain or meningeal metastases.\n3. Patients with only bone or skin metastasis as the assessable lesion.\n4. Previously suffered from other malignant tumors.\n5. Those who have used Eribulin during the advanced disease stage.\n6. Individuals with a known history of allergies to the components of the interventions; History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases and a history of organ transplantation.\n7. Any heart disease or other conditions evaluated unsuitable by the researcher.\n8. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or female patients of reproductive age who are unwilling to take effective contraceptive measures throughout the trial period.\n9. According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study (including severe bleeding tendency, history of surgery within 2 weeks, hypertension beyond drug control, serious diabetes, active infection, thyroid disease, etc.).\n10. Having a clear history of neurological or mental disorders, including epilepsy or dementia.\n11. According to the RECIST 1.1 criteria, researchers determined that patients who received the last anti-tumor regimen before enrollment did not experience disease progression.","ALL","75 Years",{"count":53,"type":22},60,[25],"This study is a prospective, multicenter, phase II randomized clinical trial. It is planned to enroll 60 patients with advanced HER2 negative breast cancer, who will be randomly assigned to the experimental group and the control group in a 1:1 ratio. The participants will receive either eribulin combined with bevacizumab or eribulin monotherapy. Every treatment cycle will last for 21 days, with weekly monitoring of blood routine, blood biochemistry and other indicators. Imaging examinations will be conducted every two cycles and the efficacy will be evaluated according to RECIST 1.1 standard. The life quality questionnaire is arranged at baseline and every 3 months after enrollment, and the long-time survival will be followed every 3 months after treatment. The primary endpoint is progression-free survival (PFS), the secondary endpoints are objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS). The investigators will also focus on the treatment-related adverse events (TRAE) and quality of life (QoL) assessment.\n\nAt the same time, this study also aims to explore the resistant mechanisms of anti-angiogenic drugs. The investigators plan to collect peripheral venous blood samples at 3 time points: baseline, during treatment, and end of treatment. All the dynamic samples will be used for transcriptome sequencing to obtain the gene sets. And based on the optimal therapeutic efficacy, all the participants will be divided into response group and non-response group. GO and KEGG enrichment analysis will be subsequently performed between different therapeutic efficacy groups to draw gene interaction networks, identify key action nodes and explain the mechanism of anti-angiogenic drug resistance.",[57,58,59,60],"Breast Neoplasms","Neoplasm Metastasis","Drug Therapy","Bevacizumab",[62,63,64,65,66,67],"breast cancer","HER2 negative","eribulin","bevacizumab","efficacy","resistant mechanism","2024-08-01",{"date":70,"type":35},"2024-08-06",{"date":68,"type":22},{"date":73,"type":22},"2026-08-01",{"name":41,"class":42},3,""]