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

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.

NCT Number	NCT06606730
Lead Sponsor	UNICANCER
Conditions	Breast Cancers, Triple Negative Breast Cancer (TNBC)
Enrollment	2,454 participants
Start Date	2025-07-23
Primary Completion	2033-01-01 (estimated)
Study Completion	2039-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-23