OncoMatch/Clinical Trials/NCT06462092
Sacituzumab Govitecan and Intrathecal Chemotherapy for Treating Leptomeningeal Metastases From Her2-negative Breast Cancer
Is NCT06462092 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Biomarker criteria
Required: HER2 (ERBB2) negative (ihc 0, ihc 1+ or ihc 2+ and ish negative)
Disease stage
Metastatic disease required
Demographics
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.
Frequently asked questions
Is NCT06462092 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify