[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592521":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":26,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GM1 400mg","EXPERIMENTAL","Albumin-paclitaxel was administered on Day 1 of each cycle, Q3W. GM1 is administered with D-1,D1,D2 every cycle",[13],"Drug: GM1",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Albumin-paclitaxel was administered on Day 1 of each cycle, Q3W. Placebo is administered with D-1,D1,D2 every cycle",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","GM1","GM1 was administered intravenously one day before the administration of each cycle of chemotherapy. The experimental group was given 400 mg of GM1 injection. Administration was carried out at D-1, D1, D2 in each cycle, with a cumulative administration of 3 times per cycle.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Placebo was administered intravenously one day before the administration of each cycle of chemotherapy. The control group was given placebo. Administration was carried out at D-1, D1, D2 in each cycle, with a cumulative administration of 3 times per cycle.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"ZeFei Jiang, Chief Physician","CONTACT","010-66947175","jzf_cscobc@csco.org.cn",[37],{"facility":38,"status":39,"city":40,"state":26,"zip":26,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"The Fifth Medical Center of the Chinese People's Liberation Army General Hospital","RECRUITING","Beijing","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":51,"role":33,"phone":34,"phoneExt":26,"email":52},"ZeFei Jiang, PHD","jzf-cscobc@csco.org.cn",{"type":54,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100592521","phase-3-gm1-prophylaxis-for-nab-paclitaxel-associated-chemotherapy-induced-peripheral-neuropathy-cipn-in-patients-with-breast-cancer-100592521",false,"NCT06994507","GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer","A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial of GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer（Gypsophila )","Inclusion Criteria:\n\n* Voluntarily sign the informed consent form;\n* Age: 18 to 75 years old;\n* Female patients with breast cancer confirmed byhistological and\u002For cytological diagnostic basis for breast cancer and are intended to receive adjuvant\u002Fneoadjuvant therapy with Albumin paclitaxel regimens;\n* ECOG: 0-1\n* Adequate organ function level\n* Glycated hemoglobin (HbA1c) \\\u003C 7.0%;\n* For women of childbearing potential: use effective contraceptive measures for contraception from the date of signing the informed consent form until 30 days after the last use of the investigatory drug.\n* Patients can accurately record or express the occurrence and severity of peripheral neuropathy through questionnaires.\n\nExclusion Criteria:\n\n* Grade ≥1 peripheral neuropathy (CTCAE grade ≥1) or any of the first 4 items of FACT\u002FGOG-Ntx ≥1;\n* There are risk factors for peripheral neuropathy (excluding peripheral neuropathy caused by chemotherapy).\n* History of another malignant tumors (except breast cancer)\n* Symptoms such as muscle pain in the limbs that interfere with the evaluate of peripheral neuropathy;\n* Uncontrolled cardiovascular and cerebrovascular system diseases or hypertension\n* Active infections that require systematic treatment, including bacteria, fungi or viruses, within one week before first study drug use; Or infectious diarrhea occurred within 4 weeks before the first study drug use;\n* Hereditary abnormal glycolipid metabolism, HIV infection or known Acquired Immune Deficiency Syndrome (AIDS); Positive syphilis antibody, active hepatitis B, active hepatitis C","FEMALE","18 Years","75 Years",{"count":66,"type":67},352,"ESTIMATED","INTERVENTIONAL",[70],"PHASE3","This study is a randomized, double-blind, multicenter, placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of GM1 in preventing chemotherapy-induced peripheral neuropathy in breast cancer patients treated with Albumin-paclitaxel chemotherapy regimen.",[73],"Chemotherapy-induced Peripheral Neuropathy (CIPN)","2025-08-05",{"date":76,"type":77},"2025-08-06","ACTUAL",{"date":79,"type":77},"2025-08-01",{"date":81,"type":67},"2027-06",{"name":5,"class":6},1]