drugset / Trial / NCT02997995

Durvalumab and Endocrine Therapy in ER+/Her2- Breast Cancer After CD8+ Infiltration Effective Immune-Attractant Exposure

NCT02997995

Phase 2 Completed 61 enrolled UNICANCER Breast International Group · collab
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

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Exemestane Small molecule 25 mg
Subject Tremelimumab Monoclonal antibody 3 mg/kg