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

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

Trial Details

NCT ID
NCT06462092
Phase
PHASE1 / PHASE2
Sponsor
Guangzhou Medical University
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Sacituzumab Govitecan
  • Pemetrexed
Locations (sample)
  • Huizhou, Guangdong, China|23.11147,114.41523

Key Eligibility Criteria

  • A clear histopathologic diagnosis of breast cancer with HER2-negative subtype (including IHC 0, IHC 1+ or IHC 2+ and ISH negative);
  • Cerebrospinal fluid cytology confirms the presence of leptomeningeal metastases; or imaging findings combined with clinical symptoms and signs are …
  • Age ≥ 18 years old.

For full eligibility, visit ClinicalTrials.gov.

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