OncoMatch/Clinical Trials/NCT07134153
Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases
Is NCT07134153 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies T-DXd for breast cancer.
Treatment: T-DXd — Multiple trials confirm systemic T-DXd efficacy in HER2+ breast cancer with leptomeningeal/brain metastases, yet median LM survival remains 3-4 months, highlighting unmet needs. While systemic therapies improve survival, intracranial disease control remains limited due to poor BBB penetration. Preclinical data show no detectable T-DXd/DXd in CSF, though intrathecal trastuzumab demonstrates preliminary safety/efficacy in HER2+ LM. This study evaluates intrathecal/intra-Ommaya T-DXd plus systemic therapy in active HER2+ meningeal/brain metastases, assessing safety, intracranial efficacy, and CSF/peripheral blood T-DXd distribution to clarify BBB penetration potential. Findings may guide novel therapeutic strategies for this high-need population.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression
Disease stage
Metastatic disease required
advanced or metastatic breast cancer
Lab requirements
Blood counts
adequate organ and bone marrow function
Kidney function
Liver function
Adequate organ and bone marrow function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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