[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"triple-negative-breast-cancertnbc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:triple-negative-breast-cancertnbc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100548332","phase-3-pm8002-or-placebo-plus-nab-paclitaxel-as-first-line-treatment-in-inoperable-locally-advancedmetastatic-tnbc-100548332",false,"NCT06419621","PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced\u002FMetastatic TNBC","A Multicenter, Randomized, Double-blind Phase III Study of PM8002 or Placebo in Combination With Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced\u002FMetastatic Triple-negative Breast Cancer(TNBC)","Inclusion Criteria:\n\n* Ability to understand and willing to provide written informed consent and to comply with scheduled visits and study procedures;\n* Female, aged 18 to 70 years (inclusive);\n* Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2. Testing results for all three markers conducted within 24 months prior to the initiation of the study by a local facility accredited by clinical research center are acceptable. If deemed necessary by the investigator during screening, subjects may provide additional biopsy to confirm the latest pathological;\n* Subjects who have not received prior systemic treatment（except endocrine therapy） for advanced breast cancer are eligible for the study. Subjects who have received Taxane-based chemotherapy during the neoadjuvant and\u002For adjuvant treatment phase are eligible, as long as the occurrence of relapse or metastasis is at least 12 months after the end of treatment;\n* Performance status as assessed by the Eastern Cooperative Oncology Group (ECOG) is 0-1;\n* Life expectancy of 12 weeks or more;\n* According to RECIST 1.1, the subject has at least 1 measurable lesion as the targeted lesion (the only bone metastasis or the only central nervous system metastasis should not be considered as a measurable lesion. A measurable lesion located at the previously irradiated radiation field or other local treatment area should not be selected as targeted lesion, unless the lesion shows unequivocal radiographic progression).\n\nExclusion Criteria:\n\n* Previous treatment with immune checkpoint agonists (such as CD137 agonists) or immune checkpoint inhibitors (such as CTLA-4, PD-1, PD-L1, LAG3 monoclonal antibody, etc.) or anti-vascular endothelial growth factor (VEGF) target drugs;\n* Has uncontrolled or symptomatic brain or spine cord metastases;\n* Those who have had other active malignant tumors within 5 years prior to the study treatment, except for those that can be treated locally and have been cured ;\n* Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg);\n* With a history of hypertensive crisis or hypertensive encephalopathy;\n* With a history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within the last 6 months prior to the start of the study treatment;\n* Adverse events resulting from prior anti-tumor therapies should be assessed and graded according to the CTCAE 5.0 criteria, subjects whose AEs have not returned to Grade 1 or below;\n* Has uncontrollable pleural, pericardial, or abdominal effusions;\n* Has received allogeneic hematopoietic stem cell transplantation or organ transplantation.","FEMALE","18 Years","70 Years",{"count":20,"type":21},360,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This multicenter, randomized, double-blind study will evaluate the safety and efficacy of PM8002 in combination with Nab-Paclitaxel compared with placebo combined with Nab-Paclitaxel as first-line treatment in inoperable locally advanced\u002Fmetastatic triple-negative breast cancer(TNBC)",[27],"Triple Negative Breast Cancer(TNBC)","RECRUITING","2025-03-09",{"date":31,"type":32},"2025-03-12","ACTUAL",{"date":34,"type":32},"2024-06-11",{"date":36,"type":21},"2028-07",{"name":38,"class":39},"Biotheus Inc.","INDUSTRY",70]