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

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Start date: Jun 15, 2024 to Jan 1, 2026
    • Study sites: 0 to 1
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description shortened, about 68 words
    • Eligibility criteria shortened, about 5 words
  2. Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description revised
    • Study title revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06462092
Lead Sponsor Guangzhou Medical University
Conditions
(from sponsor)		 Leptomeningeal Metastases
Related terms Breast Neoplasms, Meningeal Carcinomatosis
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov