drugset / Trial / NCT02997995
Durvalumab and Endocrine Therapy in ER+/Her2- Breast Cancer After CD8+ Infiltration Effective Immune-Attractant Exposure
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, multicentric, international, phase II trial testing aromatase inhibitors in combination with durvalumab in patients with CD8+ T cell infiltration (\>10% CD8+ T cells in the tumor). The trial includes two sequences: The first part of the treatment will consist in 4-6 weeks treatment with immune-attractants; in the second part, CD8+ patients will receive 6 months of durvalumab combined with exemestane.
Timeline
- Start
- 2017-02-15
- Primary completion
- 2019-07-15
- Completion
- 2020-08-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Exemestane | Small molecule | 25 mg | — |
| Subject | Tremelimumab | Monoclonal antibody | 3 mg/kg | — |