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Phase I/II Study of Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in the Management of HER2+ Breast Leptomeningeal Disease
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.
Phase I Primary Objective: - To determine the safety and MTD/recommended phase II dose (RP2D) of IT pertuzumab in combination with IT trastuzumab in the management of HER2+ breast LMD. Phase I Secondary Objectives: - To define the cerebrospinal fluid (CSF) pharmacokinetics (PK) of IT pertuzumab. - To evaluate the response rate (leptomeningeal and parenchymal) of IT trastuzumab/pertuzumab in the management of HER2+ breast LMD. - To evaluate PFS (leptomeningeal and parenchymal) following IT trastuzumab/pertuzumab in the management of HER2+ breast LMD. - To evaluate OS following IT trastuzumab/pertuzumab in the management of HER2+ breast LMD.
Herceptin (Trastuzumab); Pertuzumab (); Radiotherapy (); Trastuzumab (); rhuMAb HER2 (Trastuzumab)