S1418, 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 (ypN1mi, ypN1-3) after Neoadjuvant Chemotherapy
Categories (click each to see list of all clinical trials associated with that category): Breast
Current Status: Open to accrual
Phase: III
Principal Investigator: Krishnamurthy, Jairam
Contact Information:
Shara Graalfs
+1 402-596-3151
shara.graalfs@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT02954874#eligibility
Summary
PRIMARY OBJECTIVES:
I. 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.
SECONDARY OBJECTIVES:
I. To compare the effects of MK-3475 (pembrolizumab) on overall survival (OS) and distant recurrence-free survival (DRFS) between the two randomized arms for the PD-L1 positive patients and then all patients.
II. To assess the toxicity and tolerability of MK-3475 (pembrolizumab) in this patient population with or without radiation therapy.