Clinical Trial

Sacituzumab Govitecan and Intrathecal Chemotherapy for Treating Leptomeningeal Metastases From Her2-negative Breast Cancer

Recruiting Phase 1/2
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Summary
Leptomeningeal metastases (LM) is a lethal complication of malignant tumors, characterized by tumor cell invasion and proliferation within the subarachnoid space. LM from HER2-negative breast cancer remains challenging to treat, with a median overall survival of only 3-6 months despite aggressive therapy. This open-label, uncontrolled Phase I/II clinical study aims to evaluate the safety, feasibility, and potential efficacy of Sacituzumab Govitecan in combination with intrathecal pemetrexed chemotherapy for LM from HER2-negative breast cancer, with the objective of identifying a more effective treatment strategy.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-06-12; most recent amendment 2025-09-24.
Status change: Not Yet Recruiting → Recruiting 2025-09-24
Trial Details
NCT Number NCT06462092
Lead Sponsor Guangzhou Medical University
Conditions Leptomeningeal Metastases
Enrollment 34 participants
Start Date 2026-01-01
Primary Completion 2027-01-15 (estimated)
Study Completion 2027-06-15 (estimated)
Updated on ClinicalTrials.gov 2025-09-29