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Clinical Trial Summary

The purpose of this study is to find out if radiation therapy followed by intrathecal trastuzumab and pertuzumab is safe and will result in improved survival in HER2 positive breast cancer which has metastasized to the leptomeninges.


Clinical Trial Description

The study is designed as a prospective, single-arm, nonrandomized, open-label, phase I/II trial of radiation therapy (RT) followed by intrathecal (IT) trastuzumab/pertuzumab in the management of HER2+ breast leptomeningeal disease (LMD). Treatment will be initiated with RT, whole brain RT (WBRT) and/or focal brain/spine RT followed by IT trastuzumab/pertuzumab. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04588545
Study type Interventional
Source H. Lee Moffitt Cancer Center and Research Institute
Contact Kamran Ahmed, MD
Phone 813-745-8424
Email kamran.ahmed@moffitt.org
Status Recruiting
Phase Phase 1/Phase 2
Start date December 10, 2020
Completion date November 1, 2024

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