[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551592":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":66,"collaborators":38,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":38,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":38,"studyType":81,"phases":82,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":47,"whyStopped":38,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Guangzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Group","EXPERIMENTAL","In the Phase I cohort, a minimum of 3 patients and a maximum of 6 patients were enrolled. If DLT occurred in ≥2 patients, the dose of intrathecal pemetrexed was reduced to 10 mg, and enrollment continued with 6 consecutive patients. If DLT recurred in ≥2 patients, the trial was terminated. if DLT occurred in ≤1 patient, the study advanced to Phase II.",[13,14],"Drug: Sacituzumab Govitecan","Drug: Pemetrexed",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Sacituzumab Govitecan","Patients receive Sacituzumab Govitecan 10mg\u002Fkg by intravenous infusion on days 1 and 8. Treatment cycles are every 21 days.",[9],[22],"Trodelvy",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Pemetrexed","Intrathecal pemetrexed chemotherapy, administered via intracerebroventricular or lumbar puncture, consists of three phases: induction therapy (15 mg twice weekly for 2 weeks), consolidation therapy (once weekly for 4 consecutive weeks), and maintenance therapy (once monthly).",[9],[28],"ALIMTA",[30],{"name":31,"affiliation":32,"role":33},"Zhenyu Pan","Huizhou Hospital of Guangzhou Medical University","PRINCIPAL_INVESTIGATOR",[35,40],{"name":31,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","+8618718178286",null,"dr-zypan@163.com",{"name":41,"role":36,"phone":42,"phoneExt":38,"email":43},"Guozi Yang","+8615804302755","guoziyang_1982@163.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"The Affiliated Huizhou Hospital, Guangzhou Medical University","RECRUITING","Huizhou","Guangdong","516000","China","CN",{"type":54,"coordinates":55},"Point",[56,57],114.41523,23.11147,{"lat":57,"lon":56},[60,62,65],{"name":61,"role":36,"phone":37,"phoneExt":38,"email":39},"Zhenyu Pan, PhD,MD",{"name":63,"role":36,"phone":42,"phoneExt":38,"email":64},"Guozi Yang, PhD,MD","2023621057@gzhmu.edu.cn",{"name":61,"role":33,"phone":38,"phoneExt":38,"email":38},{"type":33,"investigatorFullName":31,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Professor","100551592","phase-1-sacituzumab-govitecan-and-intrathecal-chemotherapy-for-treating-leptomeningeal-metastases-from-her2-negative-breast-cancer-100551592",false,"NCT06462092","Sacituzumab Govitecan and Intrathecal Chemotherapy for Treating Leptomeningeal Metastases From Her2-negative Breast Cancer","A Phase I\u002FII Clinical Study of Sacituzumab Govitecan Combined With Intrathecal Chemotherapy for the Treatment of Leptomeningeal Metastases From Her2-negative Breast Cancer","Inclusion Criteria:\n\n1. A clear histopathologic diagnosis of breast cancer with HER2-negative subtype (including IHC 0, IHC 1+ or IHC 2+ and ISH negative);\n2. Cerebrospinal fluid cytology confirms the presence of leptomeningeal metastases; or imaging findings combined with clinical symptoms and signs are consistent with the diagnosis of leptomeningeal metastases;\n3. Age ≥ 18 years old.\n\nExclusion Criteria:\n\n1. Inadequate organ function: 1) Blood tests: ANC ≤ 1.5 x 10\\^9\u002FL, PLT ≤ 90 x 10\\^9\u002FL, Hb ≤ 90 g\u002FL; 2) Blood biochemistry tests: TBIL ≥ 1.5 times the upper limit of normal; 3) ALT and AST ≥ 2.5 times the upper limit of normal;\n2. Presence of serious and\u002For uncontrolled comorbidities that may affect participation: 1) Allergy to study drugs or adjuvant materials; 2) History of immunodeficiency (e.g., HIV-positive or other acquired or congenital immunodeficiency disease); 3) Severe concomitant diseases;\n3. Pregnant and breastfeeding female patients; women of childbearing age who are unwilling or unable to use effective contraception;\n4. Any other condition that, in the opinion of the investigator, makes the patient ineligible for participation in the study.","ALL","18 Years","75 Years",{"count":79,"type":80},34,"ESTIMATED","INTERVENTIONAL",[83,84],"PHASE1","PHASE2","Leptomeningeal metastases (LM) is a lethal complication of malignant tumors, characterized by tumor cell invasion and proliferation within the subarachnoid space. LM from HER2-negative breast cancer remains challenging to treat, with a median overall survival of only 3-6 months despite aggressive therapy. This open-label, uncontrolled Phase I\u002FII clinical study aims to evaluate the safety, feasibility, and potential efficacy of Sacituzumab Govitecan in combination with intrathecal pemetrexed chemotherapy for LM from HER2-negative breast cancer, with the objective of identifying a more effective treatment strategy.",[87],"Leptomeningeal Metastases",[89,90,87,18,24,91],"Breast cancer","Her2- (Human Epidermal Growth Factor Receptor 2 Negative)","Intrathecal chemotherapy","2025-09-24",{"date":94,"type":95},"2025-09-29","ACTUAL",{"date":97,"type":80},"2026-01-01",{"date":99,"type":80},"2027-06-15",{"name":5,"class":6},1]