OncoMatch/Clinical Trials/NCT06462092
Sacituzumab Govitecan and Intrathecal Chemotherapy for Treating Leptomeningeal Metastases From Her2-negative Breast Cancer
Is NCT06462092 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Sacituzumab Govitecan and Pemetrexed for leptomeningeal metastases.
Treatment: Sacituzumab Govitecan · Pemetrexed — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: HER2 (ERBB2) negative (ihc 0, ihc 1+ or ihc 2+ and ish negative)
Disease stage
Metastatic disease required
Lab requirements
Blood counts
ANC ≤ 1.5 x 10^9/L, PLT ≤ 90 x 10^9/L, Hb ≤ 90 g/L
Liver function
TBIL ≥ 1.5 times the upper limit of normal; ALT and AST ≥ 2.5 times the upper limit of normal
Inadequate organ function: 1) Blood tests: ANC ≤ 1.5 x 10^9/L, PLT ≤ 90 x 10^9/L, Hb ≤ 90 g/L; 2) Blood biochemistry tests: TBIL ≥ 1.5 times the upper limit of normal; 3) ALT and AST ≥ 2.5 times the upper limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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