[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-or-metastatic-triple-negative-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-or-metastatic-triple-negative-breast-cancer":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100635758",false,"NCT07556848","A Study of 9MW2821 Versus Chemotherapy in Participants With Previously Treated Locally Advanced or Metastatic Triple-Negative Breast Cancer","A Randomized, Open-label, Phase 3 Study to Evaluate 9MW2821 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer Who Have Previously Received Taxane-based Chemotherapy With or Without Immunotherapy and an Antibody-drug Conjugate With a Topoisomerase Inhibitor Payload","Inclusion Criteria:\n\n* Competent to comprehend, sign, and date an independent ethics committee\u002Finstitutional review board\u002Fresearch ethics board (IEC\u002FIRB\u002FREB) approved informed consent form.\n* Male or female subjects aged 18 to 75 years (including 18 and 75 years).\n* ECOG 0-1.\n* Histopathological diagnosed triple-negative breast cancer.\n* Patient has previously received taxane-based chemotherapy with or without immunotherapy and an antibody-drug conjugate with a topoisomerase inhibitor payload.\n* Suitable for one of active comparator chemotherapy assessed by investigator.\n* An archival tumor tissue sample or a fresh tissue sample should be provided.\n* Life expectancy of ≥ 12 weeks.\n* Subjects must have measurable disease according to RECIST (version 1.1).\n* Adequate organ functions.\n* Sexually active fertile participants, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.\n\nExclusion Criteria:\n\n* Preexisting treatment related toxicity Grade ≥ 2 and Grade ≥ 3 immune related adverse reactions.\n* Preexisting peripheral neuropathy Grade ≥ 2.\n* Hemoglobin A1C (HbA1c) ≥ 8%.\n* Has ocular conditions or symptoms that may increase the risk of the study.\n* History of ILD or pneumotitis, other severe or uncontrolled disease or central nervous system metastases and\u002For meningeal metastasis.\n* Previous medication does not meet the requirements.\n* Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.\n* Documented history of pulmonary embolism or clinically significant cardiac or cerebrovascular diseases .\n* Active autoimmune disease.\n* History of another malignancy .\n* Pleural, abdominal, or pericardial effusion with clinical symptoms or that require drainage treatment.\n* Not suitable to receive study treatment for other conditions as per investigator.","ALL","18 Years","75 Years",{"count":19,"type":20},356,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The purpose of this study is to compare the efficacy and safety of 9MW2821 versus investigator's choice of chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer who have previously received taxane-based chemotherapy with or without immunotherapy and an antibody-drug conjugate with a topoisomerase inhibitor payload",[26],"Locally Advanced or Metastatic Triple-negative Breast Cancer",[28],"triple-negative breast cancer","NOT_YET_RECRUITING","2026-04-28",{"date":32,"type":33},"2026-04-30","ACTUAL",{"date":35,"type":20},"2026-05",{"date":37,"type":20},"2028-09",{"name":39,"class":40},"Mabwell (Shanghai) Bioscience Co., Ltd.","INDUSTRY",""]