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.

Trial Details

NCT ID
NCT06606730
Phase
PHASE3
Sponsor
UNICANCER
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Pembrolizumab
  • Deescalation
Locations (sample)
  • Brussels, Belgium|50.85045,4.34878
  • Villejuif, France|48.7939,2.35992

Key Eligibility Criteria

  • Patient must have signed a written informed consent prior to any trial-related procedures. When the patient is physically unable to give his writte…
  • Age ≥ 18 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  • Histologically documented stage II-III breast cancer according to the primary tumour-regional lymph node anatomic staging criteria of the American …

For full eligibility, visit ClinicalTrials.gov.

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