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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 greater than 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy (MK3475-242)

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. Secondary Objectives 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. To assess the toxicity and tolerability of MK-3475 (pembrolizumab) in this patient population with or without radiation therapy. BAHO Study Objectives To examine the association between biomarkers of inflammation and quality of life and patient-reported outcomes between the two groups during and at the end of therapy. To examine the long-term and late effects of treatment on patient-reported outcomes. Additional Objectives To collect tissue and whole blood for processing and banking in anticipation of future correlative studies in this patient population.



Recruitment Status

Past Studies