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

NCT06606730 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2454

Last updated 2025-08-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pembrolizumab

Administration of pembrolizumab for 6 months

OTHER

Deescalation

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

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Joana Mourato Ribiero · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Belgium
  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06606730 on ClinicalTrials.gov