A Randomized Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With ? 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy

Study Overview

This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer.

Study Description

The purpose of this study is to compare invasive disease-free survival (IDFS) of patients with triple-negative breast cancer (TNBC) who have either >= 1 cm residual invasive breast cancer and/or positive lymph nodes (> ypN+) after neoadjuvant chemotherapy randomized to receive 1 year of MK-3475 (pembrolizumab) adjuvant therapy compared to no MK-3475 (pembrolizumab), in both the entire study population and also in the PD-L1 positive subset.

Additional Information

Participants will not be paid for their participation.


  • IRB Number: 1804152100 (S1418/BR006)
  • Research Study Identifier: TX9001
  • Principal Investigator: Tarah Ballinger, MD

Recruitment Status

Open

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