Condition: Breast Cancer · Sponsor: Fudan University
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.
This description comes directly from the study's public registry record.
Jian Zhang, MD, PhD · +8664175590 · syner2000@163.com
Yanchun Meng, MD · +8664175590 · ycmclinicaltrials@126.com
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| Fudan University Shanghai Cancer Center | Shanghai, Shanghai Municipality, China | Recruiting |
| Fudan University Shanghai Cancer Cancer | Shanghai, Shanghai Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07134153