SWOG S1418 Trial Clinical Trial Title Pembrolizumab in Treating Patients With Triple-Negative Breast Cancer Trial Status Open to Enrollment Start Date October 15, 2017 Location Doctors & Locations Trial Type Cancer - Adult Oncology Specific Condition Breast Cancer Description 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. Eligibility Criteria 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. IRB Number Central IRB Notes https://clinicaltrials.gov/ct2/show/NCT02954874 Principal Investigator Name Jacqueline Vuky, MD Contact Name Oncology Clinical Research Phone 503-413-8199 Contact Fax 503-413-6920 Contact E-Mail oncologyresearch@lhs.org Last Updated: Wednesday, January 27, 2021 12:57:00 PM