Wednesday, December 19, 2018 MAC24 (SWOG 1418) (NCT02954874), A Randomized Phase III Trial to Evaluate the Efficacy and Safety of MK3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with ≥ 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy, has been activated in Canada . This trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Eligibility: Histologicaly confirmed triple negative breast cancer, must not have metastatic or locally recurrent disease, must have available minimum of five unstained slides from the residual (post-neoadjuvant) invasive tumor in primary site or lymph node. Patients must have had neoadjuvant chemotherapy followed by surgery, completed their final breast surgery, must be 18 years or older, and Zubrod Performance Status of 2 or less Objectives: Primary objective is to compare invasive disease-free survival of patients with triple-negative breast cancer 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 adjuvant therapy compared to no MK-3475, in both the entire study population and also in the PD-L1 positive subset. Secondary objectives: 1. To compare the effects of MK-3475 on overall survival and distant recurrence-free survival between the two randomized arms for the PD-L1 positive patients and then all patients.2. To assess the toxicity and tolerability of MK-3475 in this patient population with or without radiation therapy. BAHO Study objectives: 1.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 and to examine the long-term and late effects of treatment on patient-reported outcomes. For more information please contact the trail coordinator: Dora Baczyk or access the CCTG trial page here: https://www.ctg.queensu.ca/trials/breast/mac24/
