[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635758":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":26,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":80,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Mabwell (Shanghai) Bioscience Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: 9MW2821","EXPERIMENTAL","Participants will receive intravenous (IV) infusion of 9MW2821 as per protocol",[13],"Drug: 9MW2821",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Comparator: Investigator's Choice of Chemotherapy","ACTIVE_COMPARATOR","Participants will receive investigator's choice of chemotherapy determined prior to randomization from 1 of the 4 allowed regimens as per protocol:\n\neribulin, or vinorelbine or capecitabine or gemcitabine.",[19],"Drug: Chemotherapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","9MW2821","Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Chemotherapy","Participants will receive investigator's choice of chemotherapy determined prior to randomization from 1 of the 4 allowed regimens as per protocol: eribulin, or vinorelbine or capecitabine or gemcitabine.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Jiong Wu","CONTACT","021-64175590","wujiong1122@vip.sina.com",{"name":38,"role":34,"phone":35,"phoneExt":26,"email":39},"Jian Zhang","syner2000@163.com",[41],{"facility":42,"status":26,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality","200032","China","CN",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},[55,56],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"name":38,"role":34,"phone":35,"phoneExt":26,"email":39},{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100635758","phase-3-a-study-of-9mw2821-versus-chemotherapy-in-participants-with-previously-treated-locally-advanced-or-metastatic-triple-negative-breast-cancer-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":70,"type":71},356,"ESTIMATED","INTERVENTIONAL",[74],"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",[77],"Locally Advanced or Metastatic Triple-negative Breast Cancer",[79],"triple-negative breast cancer","NOT_YET_RECRUITING","2026-04-28",{"date":83,"type":84},"2026-04-30","ACTUAL",{"date":86,"type":71},"2026-05",{"date":88,"type":71},"2028-09",{"name":5,"class":6},1]