[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592521":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":26,"id":54,"slug":26,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":26,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":26,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":26,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"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,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"The Fifth Medical Center of the Chinese People's Liberation Army General Hospital","RECRUITING","Beijing","China",{"type":43,"coordinates":44},"Point",[45,46],116.39723,39.9075,{"lat":46,"lon":45},[49],{"name":50,"role":33,"phone":34,"phoneExt":26,"email":51},"ZeFei Jiang, PHD","jzf-cscobc@csco.org.cn",{"type":53,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":64,"type":65},352,"ESTIMATED","INTERVENTIONAL",[68],"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.",[71],"Chemotherapy-induced Peripheral Neuropathy (CIPN)","2025-08-05",{"date":74,"type":75},"2025-08-06","ACTUAL",{"date":77,"type":75},"2025-08-01",{"date":79,"type":65},"2027-06",{"name":5,"class":6},1]