drugset / Trial / NCT04454528
BreastVAX: Radiation Boost to Enhance Immune Checkpoint Blockade Therapy
Non-randomizedSequentialOpen-labelTreatment
Summary
The primary objective is to determine the feasibility of combining pembrolizumab with a single fraction radiation boost in patients with early/ operable breast cancer. The secondary objectives are to assess clinical response on pre- and post-treatment clinical, imaging, and histology exams, and to assess immune response on pre and post treatment blood and tissue samples by tracking change in Ki67 + CD8 T cells in peripheral blood and in extent of tumor infiltrating lymphocytes. A clinically significant partial response is defined as \>30% tumor shrinkage post-clinical trial intervention.
Timeline
- Start
- 2020-12-07
- Primary completion
- 2026-08
- Completion
- 2027-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pembrolizumab | Monoclonal antibody | 200 mg | — |