drugset / Trial / NCT03546686
Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast Cancer
Phase 2
Active not recruiting
51 enrolled
University of Texas Southwestern Medical Center
American Society of Clinical Oncology · collabBoston Scientific Corporation · collabBristol-Myers Squibb · collabSusan G. Komen Breast Cancer Foundation · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the impact of pre-operative cryoablation, and immune checkpoint inhibition (ICI) on on 3-year Event Free Survival (EFS), in women with residual hormone receptor negative, HER2-negative ("triple negative") resectable breast cancer after taxane-based neoadjuvant chemotherapy.
Timeline
- Start
- 2019-11-12
- Primary completion
- 2026-06
- Completion
- 2028-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | — | — |