drugset / Trial / NCT06072612
Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor \[Retifanlimab\], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.
Timeline
- Start
- 2023-12-05
- Primary completion
- 2027-12
- Completion
- 2028-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Carboplatin | Small molecule | — | — |
| Subject | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |
| Subject | Eribulin | Small molecule | — | — |
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | 0.1 ug | Intravenous |
| Subject | Retifanlimab | Monoclonal antibody | 375 mg | — |
| Subject | SV-BR-1-GM | Vaccine | — | Intrathecal |
| Subject | Vinorelbine | Small molecule | — | — |