[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633933":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":49,"locations":55,"responsibleParty":79,"collaborators":11,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":11,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":11,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":11,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"JSKN016","EXPERIMENTAL",null,[13],"Drug: JSKN016 Injection",{"label":15,"type":16,"description":11,"interventionNames":17},"Treatment of Physician's Choice","ACTIVE_COMPARATOR",[18,19,20,21,22],"Drug: Eribulin Mcsilate Injection","Drug: Vinorelbine Tartrate Injection","Drug: Capecitabine Tablets","Drug: Gemcitabine Hydrochloride for Injection","Drug: Sacituzumab Govitecan for Injection",[24,29,33,37,41,45],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"DRUG","JSKN016 Injection","Injection; 100 mg (4.0 mL)\u002Fvial. Dosage: 6 mg\u002Fkg administered via intravenous infusion on Day 1 of each 21-day cycle",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"Eribulin Mcsilate Injection","Injection; 2 mL:1 mg (0.5 mg\u002FmL). Dosage: 1.4 mg\u002Fm² administered via intravenous bolus on Day 1 and Day 8 of each 21-day cycle",[15],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"Vinorelbine Tartrate Injection","Injection; 1 mL:10 mg (10 mg\u002FmL). Dosage: 25 mg\u002Fm² administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle",[15],{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":11},"Capecitabine Tablets","Tablet; 0.15 g and 0.5 g. Dosage: 1000-1250 mg\u002Fm² orally once daily on Days 1-14 of each 21-day cycle (14 days on\u002F7 days off)",[15],{"type":25,"name":42,"description":43,"armGroupLabels":44,"otherNames":11},"Gemcitabine Hydrochloride for Injection","Injection; 0.2 g. Dosage: 1000 mg\u002Fm² administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle",[15],{"type":25,"name":46,"description":47,"armGroupLabels":48,"otherNames":11},"Sacituzumab Govitecan for Injection","Injection; 180 mg\u002Fvial. Dosage: 10 mg\u002Fkg administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle",[15],[50],{"name":51,"role":52,"phone":53,"phoneExt":11,"email":54},"Yuan Huang","CONTACT","0512-62850800","yuanhuang@alphamabonc.com",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Sun Yat-sen Memorial Hospital, Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","510289","China","CN",{"type":65,"coordinates":66},"Point",[67,68],113.25,23.11667,{"lat":68,"lon":67},[71,75],{"name":72,"role":52,"phone":73,"phoneExt":11,"email":74},"Herui Yao, MD","13500018020","yaoherui@163.com",{"name":76,"role":52,"phone":77,"phoneExt":11,"email":78},"Jian Zhang, MD","021-64175590","syner2000@163.com",{"type":80,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100633933","phase-3-a-phase-iii-study-of-jskn016-versus-treatment-of-physicians-choice-in-patients-with-triple-negative-breast-cancer-who-have-failed-standard-of-care-100633933",false,"NCT07533123","A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care","A Randomized, Controlled, Open-Label Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic Triple-Negative Breast Cancer Who Have Failed at Least Two Lines of Prior Systemic Therapy","Inclusion Criteria:\n\n* Voluntarily sign the Informed Consent Form (ICF).\n* Age ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 3 months.\n* Histologically and\u002For cytologically confirmed diagnosis of Triple-Negative Breast Cancer (TNBC) based on pathology reports from the most recent biopsy or other pathological specimens.\n* Failure of at least 2 prior lines of systemic chemotherapy.\n* At least one measurable extracranial lesion per Response Evaluation Criteria in Solid -Tumors (RECIST) v1.1.\n* Agree to provide a tumor tissue specimen.\n* Adequate organ and bone marrow function.\n* Recovery from prior treatment-related toxicities to ≤ Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, or as specified in the protocol for eligibility.\n* Assessed by the investigator as suitable to receive one of the following: eribulin, capecitabine, gemcitabine, vinorelbine, or sacituzumab govitecan.\n* Female participants of childbearing potential must have a negative serum\u002Furine pregnancy test within 7 days prior to randomization and agree to contraception during the trial.\n\nExclusion Criteria:\n\n* Prior treatment with a topoisomerase I inhibitor-based antibody-drug conjugate (ADC), with the exception of TROP2-targeted ADCs.\n* Diagnosis of another malignancy within 5 years prior to randomization, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, papillary thyroid carcinoma, cervical carcinoma in situ, and other carcinomas in situ.\n* Presence of cerebrovascular or cardiovascular diseases or risk factors.\n* Inadequate washout from prior therapies prior to randomization.\n* Presence of active central nervous system (CNS) metastases without prior local treatment; presence of metastases or compression of the brainstem, meninges, or spinal cord; or history of carcinomatous meningitis.\n* Presence of severe or uncontrolled concomitant diseases that may affect safety or compliance.\n* Tumor invasion of adjacent vital organs or blood vessels (such as the heart, esophagus, superior vena cava, etc.) or risk of developing an esophagotracheal fistula or esophagopleural fistula.\n* Active hepatitis B; active hepatitis C.\n* Positive test for human immunodeficiency virus (HIV) or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection; known active tuberculosis infection.\n* History of allogeneic bone marrow or organ transplantation.\n* History of significant ophthalmic diseases.\n* History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment.","ALL","18 Years","75 Years",{"count":92,"type":93},364,"ESTIMATED","INTERVENTIONAL",[96],"PHASE3","Primary Endpoint of this Study:\n\nTo compare Progression-Free Survival (PFS) (as assessed by a Blinded Independent Review Committee \\[BIRC\\] based on Response Evaluation Criteria in Solid Tumors \\[RECIST v1.1\\]) between JSKN016 and Treatment of Physician's Choice (TPC) in participants with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC).\n\nTo compare Overall Survival (OS) between JSKN016 and TPC in the treatment of unresectable locally advanced, recurrent, or metastatic TNBC.",[99],"Triple Negative Breast Cancer","2026-04-14",{"date":102,"type":103},"2026-04-16","ACTUAL",{"date":105,"type":93},"2026-03-17",{"date":107,"type":93},"2030-03-17",{"name":5,"class":6},1]