[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635758":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":31,"studyPopulation":31,"armGroups":40,"interventions":53,"overallOfficials":31,"centralContacts":63,"locations":72,"responsibleParty":89,"collaborators":31,"id":91,"slug":31,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":31,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":31,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":111,"whyStopped":31,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Mabwell (Shanghai) Bioscience Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Overall Survival","Time from the date of randomization until the date of death from any cause","Up to approximately 2 years",[14,17,20,23,26,29,32],{"measure":15,"description":16,"timeFrame":12},"Objective Response Rate per investigator","The percentage of subjects who experience a best response of either CR or PR.",{"measure":18,"description":19,"timeFrame":12},"Duration of Response per investigator","Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause.",{"measure":21,"description":22,"timeFrame":12},"Time to response per investigator","Time from the date of randomization to the date of CR or PR.",{"measure":24,"description":25,"timeFrame":12},"Disease Control Rate per investigator","The percentage of subjects who experience a best response of CR, PR or stable disease (SD).",{"measure":27,"description":28,"timeFrame":12},"Progression Free Survival per investigator","Time from the date of first randomization to the earliest date of documented disease progression per radiological evidence or death from any cause.",{"measure":30,"description":31,"timeFrame":12},"Incidence of adverse events",null,{"measure":33,"description":31,"timeFrame":12},"Incidence of Anti-Drug Antibody (ADA)",{"allocation":35,"interventionModel":36,"interventionModelDescription":31,"primaryPurpose":37,"observationalModel":31,"timePerspective":31,"maskingInfo":38},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":39,"maskingDescription":31,"whoMasked":31},"NONE",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"Experimental: 9MW2821","EXPERIMENTAL","Participants will receive intravenous (IV) infusion of 9MW2821 as per protocol",[46],"Drug: 9MW2821",{"label":48,"type":49,"description":50,"interventionNames":51},"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.",[52],"Drug: Chemotherapy",[54,59],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":31},"DRUG","9MW2821","Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol",[42],{"type":55,"name":60,"description":61,"armGroupLabels":62,"otherNames":31},"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.",[48],[64,69],{"name":65,"role":66,"phone":67,"phoneExt":31,"email":68},"Jiong Wu","CONTACT","021-64175590","wujiong1122@vip.sina.com",{"name":70,"role":66,"phone":67,"phoneExt":31,"email":71},"Jian Zhang","syner2000@163.com",[73],{"facility":74,"status":31,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality","200032","China","CN",{"type":81,"coordinates":82},"Point",[83,84],121.45806,31.22222,{"lat":84,"lon":83},[87,88],{"name":65,"role":66,"phone":67,"phoneExt":31,"email":68},{"name":70,"role":66,"phone":67,"phoneExt":31,"email":71},{"type":90,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","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":101,"type":102},356,"ESTIMATED","INTERVENTIONAL",[105],"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",[108],"Locally Advanced or Metastatic Triple-negative Breast Cancer",[110],"triple-negative breast cancer","NOT_YET_RECRUITING","2026-04-28",{"date":114,"type":115},"2026-04-30","ACTUAL",{"date":117,"type":102},"2026-05",{"date":119,"type":102},"2028-09",{"name":5,"class":6},1]