drugset / Trial / NCT04443348
Pre-op Pembro + Radiation Therapy in Breast Cancer (P-RAD)
Phase 2
Active not recruiting
120 enrolled
Laura M. Spring, MD
Breast Cancer Research Foundation · collabMerck Sharp & Dohme LLC · collabTranslational Breast Cancer Research Consortium · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This research trial is studying a combination of neoadjuvant radiotherapy (RT), immunotherapy (pembrolizumab) and chemotherapy for lymph node-positive, triple negative (TN) or hormone receptor positive/HER2-negative breast cancer. The names of the study interventions involved in this study are: * Radiation Therapy (RT) * Immunotherapy: Pembrolizumab (MK-3475) * Chemotherapies: * Paclitaxel * Doxorubicin (also called Adriamycin) * Cyclophosphamide * Carboplatin (optional, and in TN only) * Capecitabine (optional, and in TN only)
Timeline
- Start
- 2020-12-16
- Primary completion
- 2025-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | — | Intravenous |
| Background | Capecitabine | Small molecule | — | Oral |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Doxorubicin | Other / unclassified | — | Intravenous |
| Background | Paclitaxel | Small molecule | — | Intravenous |