Plain-English translation of NCT06462092 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.
This trial is testing combined with intrathecal chemotherapy for patients whose HER2-negative breast cancer has spread to the lining of the brain and spinal cord (a serious condition called leptomeningeal metastases). The medication works in two ways: one drug is given through an IV, and the other is delivered directly into the fluid surrounding the brain and spinal cord to target cancer cells where they hide.
Leptomeningeal metastases from breast cancer is a difficult-to-treat condition with limited options. This trial exists to see if combining these two chemotherapy approaches—one systemic and one delivered directly to the brain—can improve how well this treatment works and help patients live longer.
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You would receive the IV medication on days 1 and 8 of each 21-day treatment cycle, along with chemotherapy injected into the fluid around your brain starting on day 2. Treatment starts with an intensive phase (twice weekly for 2 weeks), moves to a consolidation phase (once weekly for 4 weeks), and if you respond well, continues with maintenance therapy (once monthly) until your cancer progresses or side effects become too severe. You'll have regular blood tests and imaging to monitor how you're responding.
AI-generated summary from trial data · Sep 4, 2026 · Not medical advice
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