drugset / Trial / NCT06606730

Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer

NCT06606730 ↗

Phase 3 Recruiting 2454 enrolled UNICANCER
RandomizedParallel-groupOpen-labelTreatment

Summary

OPT-PEMBRO trial is a pragmatic, multicentre, international, prospective, non-inferiority, two-arms, randomised (1:1), open-label, Phase III clinical study. The main goal of this research is to determine if patients with triple-negative breast cancer, who experience a complete response after neoadjuvant treatment, have the same chance of avoiding cancer recurrence whether they stop pembrolizumab or continue taking it for an additional 6 months. This research will also take into account patients tolerance to treatment and quality of life.

Timeline

Start
2025-07-23
Primary completion
2033-01-01
Completion
2039-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody — —