[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leptomeningeal-metastasis-of-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leptomeningeal-metastasis-of-breast-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100642337","quality-of-life-for-patients-with-breast-cancer-brain-metastases-and-leptomeningeal-disease-100642337",false,"NCT07659652","Quality of Life for Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease","Prospective Evaluation of Quality of Life in Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease","Inclusion Criteria:\n\n1. Be male or female 18 years of age or older.\n2. Have stage 4 (metastatic) breast cancer with spread to the brain parenchyma and\u002For leptomeninges.\n3. Have the intention to start or continue anticancer therapy.\n4. Be able to provide informed consent.\n5. Be able to speak and read English.\n\nExclusion Criteria:\n\nParticipants who are not on any anticancer therapy and are not planning to start any anticancer therapy will be excluded from the study.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","OBSERVATIONAL","Central nervous system (CNS) metastases including breast cancer brain metastases (BCBMs) and leptomeningeal disease (LMD) are common affecting up to 30% of patients with metastatic breast cancer (MBC). The goal of this research is to understand symptom burden and quality of life trajectories in this population and how treatments guide care management decisions.",[24,25,26,27,28],"Breast Cancer, Quality of Life","Breast Cancer, Metastatic","Breast Cancer, Metastatic Breast Cancer","Leptomeningeal Metastasis of Breast Cancer","Brain Metastases From Breast Cancer",[30],"Quality of Life","NOT_YET_RECRUITING","2026-06-15",{"date":34,"type":35},"2026-06-22","ACTUAL",{"date":32,"type":20},{"date":38,"type":20},"2035-12-31",{"name":40,"class":41},"University of California, San Francisco","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100565139","study-in-patients-with-breast-cancer-leptomeningeal-metastasis-100565139","NCT06638294","Study in Patients With Breast Cancer Leptomeningeal Metastasis","A Translational Observational Biorepository and Management Study in Patients With Breast Cancer Leptomeningeal Metastasis: The BioLept Study","BioLept","Inclusion Criteria:\n\n* Male or female, aged 18 or older\n* History of breast cancer (any subtype)\n* Suspected breast cancer-related leptomeningeal metastasis (i.e., by clinical signs or symptoms (i.e., peri-oral dysesthesia, unexplained new neurological symptoms in the absence of brain metastasis), radiographic, or by cerebrospinal fluid analysis), whereby patient will be treated along an leptomeningeal disease paradigm.\n* Previous central nervous system metastasis (including leptomeningeal disease or brain metastasis) is eligible.\n* Eastern Cooperative Oncology Group (ECOG) score of ≤3 or Karnofsky performance status ≥60.\n\nExclusion Criteria:\n\n* Suspected central nervous system recurrence of hematologic malignancy, lymphoma or other solid tumor\n* Not eligible for treatment of leptomeningeal disease.","18 Weeks",{"count":53,"type":20},30,"Traditional clinical trials in patients with breast cancer leptomeningeal disease (LMD) are challenging as patients often have a rapidly progressive course and prognosis is poor, making meeting standard eligibility difficult. Furthermore, there is limited information about the biology of LMD. The investigators thus propose a study that is as inclusive as possible, which will allow the investigators to collect biospecimens and clinical outcomes to learn more about LMD biology, but still potentially provide benefit for patients, by providing patients rapid diagnostics and multi-disciplinary treatment recommendations.",[27],[57],"breast cancer","RECRUITING","2025-11-25",{"date":61,"type":35},"2025-11-28",{"date":63,"type":35},"2024-11-25",{"date":65,"type":20},"2028-12",{"name":67,"class":41},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",2,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":42},"100557890","phase-2-efficacy-and-safety-of-intrathecal-administration-of-thiotepa-in-combination-with-methotrexate-in-breast-cancer-with-leptomeningeal-metastasis-100557890","NCT06543992","Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate in Breast Cancer With Leptomeningeal Metastasis","Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate Via the Ommaya Reservoir in Breast Cancer With Leptomeningeal Metastasis: a Phase II Multicenter Clinical Trial","Inclusion Criteria:\n\n1. Patient is an adult female ≥18 and ≤75 years old at the time of informed consent.\n2. ECGO rating 0-3.\n3. Histologically or cytologically confirmed breast cancer.\n4. Cerebrospinal fluid cytology combined with central nervous system function and brain imaging demonstrated the diagnosis of breast cancer with meningeal metastases;\n5. Patients can be implanted or have been implanted with Ommaya reservoirs;\n6. Patient must have at least one measurable lesion (according to RECIST 1.1 criteria);\n7. Postmenopausal or pre\u002Fperimenopausal female patients are eligible for enrolment; pre or perimenopausal female patients must be willing to receive LHRHa during the study period.\n8. All patients were required to meet the following laboratory biochemical values prior to enrolment:\n\n   * Haematology: Hb ≥90 g\u002FL, WBC ≥3.5×109\u002FL, ANC ≥1.5×109\u002FL, PLT ≥100×109\u002FL;\n   * Liver function: for those without liver metastases, AST, ALT, ALP ≤2.5 times the upper limit of normal values, and ≤1.25 x the upper limit of normal values for total bilirubin; for those with liver metastases, AST, ALT, ALP ≤ 5 times the upper limit of normal value, and total bilirubin ≤ 1.5 x upper limit of normal value.\n\nExclusion Criteria:\n\n1. Patients with other malignant tumors, excluding basal cell carcinoma and carcinoma in situ\n2. Patients with severe or uncontrolled systemic disease, including uncontrolled hypertension or active bleeding tendency\n3. The investigator considers the patient unsuitable for entry into this study.\n4. Patients with toxicity from prior therapy that has not returned to normal or NCI-CTCAE grade 5.0\n5. Patients who have a drug allergy or metabolic disorder to the drugs in this regimen\n6. Pregnant or lactating women (women of childbearing age must have had a negative pregnancy test within 14 days prior to the first dose; if positive, pregnancy must be ruled out by ultrasound).\n7. Patients who are concurrently enrolled in other clinical studies","FEMALE","75 Years",{"count":79,"type":20},22,"INTERVENTIONAL",[82],"PHASE2","Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis",[27],[86,87,88],"methotrexate","thiotepa","intrathecal chemotherapy","2024-08-06",{"date":91,"type":35},"2024-08-09",{"date":93,"type":35},"2024-07-13",{"date":95,"type":20},"2026-12-13",{"name":97,"class":41},"The First Affiliated Hospital with Nanjing Medical University"]