drugset / Trial / NCT06100874
A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)
NaSingle-groupOpen-labelTreatment
Summary
This research study is being done to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in metastatic HER2+ breast cancer. The names of the study drugs used in this research study are: * Sacituzumab govitecan (a type of antibody-drug conjugate) * Trastuzumab (Herceptin) (a type of monoclonal antibody) * Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta) (a type of recombinant monoclonal antibody) * Trastuzumab biosimilar drug
Timeline
- Start
- 2023-11-20
- Primary completion
- 2026-02-09
- Completion
- 2027-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sacituzumab Govitecan | Monoclonal antibody | 180 mg | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 150 mg | Intravenous |
| Subject | Trastuzumab and Hyaluronidase-oysk | Monoclonal antibody | 6 ml | Subcutaneous |