SWOG-S1418 NRG-BR006

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

Principal Investigator

Lajos Pusztai

Status

Disease Site

Breast [BR] Breast

Phase

III

Developmental Therapeutics

No

Primary Objective

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

Protocol Documents
The protocol and related documents are available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.

Note: This study is a collaboration between SWOG and NRG Oncology. SWOG is the lead organization.

Patient Population

Patients with TNBC, ≥1cm residual invasive breast cancer, or any + LN after neoadjuvant chemotherapy, followed by surgery

Target Accrual

1000