drugset / Trial / NCT04588545
Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease
Phase 1/2
Active not recruiting
33 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Genentech, Inc. · collab
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2020-12-10
- Primary completion
- 2027-04
- Completion
- 2027-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pertuzumab | Monoclonal antibody | 10 mg | Intrathecal |
| Subject | Pertuzumab | Monoclonal antibody | 20 mg | Intrathecal |
| Subject | Pertuzumab | Monoclonal antibody | 40 mg | Intrathecal |
| Subject | Pertuzumab | Monoclonal antibody | 80 mg | Intrathecal |
| Subject | Trastuzumab | Monoclonal antibody | 80 mg | Intrathecal |