drugset / Trial / NCT04243616
Cemiplimab in High-risk or Locally Advanced Luminal and Triple Negative Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is a single-arm, open-label, phase 2 study that will enroll 36 subjects, who have pathologically proven diagnosis of invasive breast cancer, clinical stage tumor 1-3 (cT1-T3), node 0-3 (cN0-N3), metastasis 0 (cM0), hormone receptor positive (HR+) (estrogen-receptor-positive (ER+) and/or progesterone-receptor-positive (PR+) human epidermal growth factor receptor 2 (HER2) negative or hormone receptor-negative (HR-) (estrogen-receptor-negative (ER-) and progesterone-receptor-negative (PR-) human epidermal growth factor receptor 2 (HER2) negative/triple-negative breast cancer.
Timeline
- Start
- 2020-03-05
- Primary completion
- 2025-08-11
- Completion
- 2030-08-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cemiplimab | Monoclonal antibody | 350 mg | Intravenous |
| Background | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 600 g | Intravenous |
| Background | Doxorubicin | Other / unclassified | 60 g | Intravenous |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |