Clinical Trial

Intrathecal Chemotherapy Through Ommaya Reservoir Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis

Recruiting Phase 4
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Record status
This record was last updated November 25, 2025 (before its estimated January 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a prospective, multicenter, randomized controlled, open-label investigator-initiated clinical study to evaluate the clinical efficacy and quality of life of intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy versus systemic chemotherapy alone in patients with Her-2 negative breast cancer with leptomeningeal metastasis.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-01-26; most recent amendment 2025-11-20.
Trial Details
NCT Number NCT06230055
Lead Sponsor Fudan University
Conditions HER2-negative Breast Cancer, Leptomeningeal Metastasis
Enrollment 37 participants
Start Date 2024-01-05
Primary Completion 2026-01-01 (estimated)
Study Completion 2027-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-25