Short-term Pre-OPerative Durvalumab (MEDI 4736) in Early Small Triple Negative Breast Cancer Patients (POP-Durva)
Status:
Recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
This study aims to evaluate the efficacy and safety of preoperative Durvalumab in patients
with early small (cT1N0) triple negative breast cancer tumors. This preoperative study will
recruit patients with early HR-negative breast cancer all invasive types (ER < 1%, PR < 1%,
HER2 negative), not candidate for neoadjuvant chemotherapy and eligible for a short-term
pre-operative treatment with Durvalumab followed by breast surgery.
A total of 200 patients are planned to be enrolled in the study. Patients will receive IV
durvalumab 10mg/kg monotherapy every 2 weeks for a total of 6 weeks, followed by a surgery at
Day 42.