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

StatusRecruiting
PhasePhase 4
Started2024-01-05
View on ClinicalTrials.gov ↗
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.

Amendment history

2025-11-20
Study Status, Oversight, Arms and Interventions v4
InterventionsOmmaya reservoir (Device), Systematic chemotherapy (Drug)→Intrathecal chemotherapy (Drug), Ommaya reservoir (Device), Systematic chemotherapy (Drug)
2025-05-20
Study Status, Oversight, Arms and Interventions v3
Re-verified, no change to tracked fields
2025-04-17
Study Status, Study Design, Arms and Interventions v2
Enrollment target48→37
2024-03-25
Study Status, Conditions v1
Start dateestimated 2024-03-01→confirmed 2024-01-05
2024-01-26
Original filing
Fudan University
624 trials monitored
See 9 trials at risk
Breast Cancer
5,180 trials monitored
See 256 trials at risk
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.
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