SWOG S1418

This randomized phase III trial studies how well pembrolizumab works in treating triple-negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

• Patients must have histologically confirmed ER-, PR- and HER2-negative (triple-negative, TNBC) with residual invasive breast cancer, after completion of neoadjuvant chemotherapy. Residual disease must be ≥ 1 cm in greatest dimension, and/or have positive lymph nodes (ypN+) observed on pathologic exam
• Patients must be women or men ≥ 18 years of age
• Patients must have Zubrod Performance Status ≤ 2
• Patients must not have metastatic disease
• It is preferred that axillary lymph node sampling is performed after completion of neoadjuvant chemotherapy to allow more accurate assessment of pathologic response. Patients must have a complete axillary lymph node dissection after neoadjuvant chemotherapy in the following situations
•     Patients had documented pathologic involvement of the axillary nodes (FNA or core biopsy) before neoadjuvant chemotherapy and had sentinel node biopsy after neoadjuvant chemotherapy with positive sentinel node(s)
•     Patient had documented pathologic involvement of the axillary nodes (FNA or core biopsy) before neoadjuvant chemotherapy and had only 1 sentinel lymph node removed after neoadjuvant chemotherapy
• Patients must have had neoadjuvant chemotherapy followed by surgery. The recommended neoadjuvant treatment should include 16-24 weeks of a third generation chemotherapy regimen as recommended by NCCN guidelines for triple negative breast cancer
• Patients may receive post-operative (adjuvant) chemotherapy for up to 24 weeks of duration after completion of surgery at the discretion of the treating physician
• Patients must have completed their final breast surgery
• Patients must not have had prior immunotherapy with anti-PD-L1, anti-PD-1, anti-CTLA4 or similar drugs
• Patients must not have an active infection requiring systemic therapy
• No other prior invasive malignancy is allowed except for the following: adequately treated basal (or squamous cell) skin cancer, in situ breast or cervical cancer. Stage I or II invasive cancer treated with a curative intent without evidence of disease recurrence for at least five years

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.