Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 5, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT02422641). This is a study registration, not published results. Lead sponsor: Wake Forest University Health Sciences. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 16 participants (ESTIMATED). Conditions: Metastatic Breast Cancer, Leptomeningeal Disease. Interventions: DRUG: High-dose Methotrexate (8 gm/m2; HD-MTX). Primary outcome measures: Overall Survival (at 12 weeks) , 12 weeks. Brief summary: This study is a prospective evaluation of systemic, intravenous high-dose methotrexate (HD-MTX, 8 g/m2) in patients with triple negative, HER2-positive, and hormone refractory breast cancer with leptomeningeal metastasis (LMD) with or without brain parenchymal involvement.