drugset / Trial / NCT07454668
Trastuzumab Deruxtecan + Stereotactic Radiosurgery (SRS) in HER2+ Breast Cancer Brain Metastases
Phase 1
Not yet recruiting
20 enrolled
Baptist Health South Florida
National Brain Tumor Society · collab
NaSingle-groupOpen-labelTreatment
Summary
A phase I clinical trial (a type of research study) for people with human epidermal growth factor receptor 2 (HER-2) positive breast cancer with metastasis to the brain. This research study will evaluate how well brain metastases can be controlled using a type of radiation therapy known as stereotactic radiosurgery (SRS) when combined with the therapeutic agent Trastuzumab Deruxtecan (T-DXd). The combined use of SRS with T-DXd is considered investigational.
Timeline
- Start
- 2026-06
- Primary completion
- 2028-07
- Completion
- 2029-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 3.2 mg/kg | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 4.4 mg/kg | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 5.4 mg/kg | Intravenous |