drugset / Trial / NCT03356860
Safety and Efficacy of Durvalumab Combined to Neoadjuvant Chemotherapy in Localized Luminal B HER2(-) and Triple Negative Breast Cancer.
Phase 1/2
Completed
57 enrolled
Grand Hôpital de Charleroi
Cliniques universitaires Saint-Luc- Université Catholique de Louvain · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The study has a phase Ib and a phase II part. * The phase Ib aims to evaluate the safety and tolerability of durvalumab in combination with a dose- dense EC regimen in a neoadjuvant setting for early breast cancer. * The phase II aims to explore the efficacy of durvalumab in combination with a dose-dense EC regimen in a neoadjuvant setting for early breast cancer.
Timeline
- Start
- 2017-04-13
- Primary completion
- 2022-11-21
- Completion
- 2023-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Epirubicin | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |