RecruitingPhase 3NCT06606730

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

OPTimizing Adjuvant Prescription of PEMBROlizumab in Patients With Early-stage Triple-negative Breast Cancer Achieving Pathologic Complete Response After Standard Neoadjuvant Chemotherapy and Pembrolizumab

Sponsor

UNICANCER

Enrollment

2,454 participants

Start Date

Jul 23, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancers

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether people with triple-negative breast cancer who had a complete response to pre-surgery chemotherapy with pembrolizumab still benefit from continuing pembrolizumab after surgery. You may be eligible if... - You are 18 or older with an ECOG performance status of 0–2 - You have stage II or III triple-negative breast cancer (ER/PR ≤10%, HER2-negative) - You received at least 6 cycles of neoadjuvant chemotherapy combined with pembrolizumab - There was no remaining invasive cancer in your breast or lymph nodes after surgery - You have had adequate surgical removal of all visible cancer You may NOT be eligible if... - Your cancer is not triple-negative breast cancer - You did not complete neoadjuvant chemotherapy with pembrolizumab before surgery - There was residual invasive disease remaining after surgery - You do not meet ECOG or other health status criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Administration of pembrolizumab for 6 months

OTHERDeescalation

Patients will be followed up according to standard practice for 4 years

Locations(2)

Cliniques Universitaires Saint Luc Brussels

Brussels, Belgium

Institut Gustave Roussy

Villejuif, France

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NCT06606730

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