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SWOG S1418 is the trial that will say whether a year of pembrolizumab after surgery, on its own, helps women whose triple-negative breast cancer survived pre-operative chemotherapy. It finished recruiting 1,195 patients and is due to report from 2026.
SWOG S1418/NRG BR006 (NCT02954874) randomised 1,195 patients with triple-negative breast cancer and residual invasive disease of at least 1 cm or positive lymph nodes (ypN1mi to ypN3) after neoadjuvant chemotherapy to one year of pembrolizumab or observation, with radiotherapy per standard of care; the primary endpoint is invasive disease-free survival, with fatigue and physical function as co-primary patient-reported endpoints. It opened in January 2017, before KEYNOTE-522 made neoadjuvant pembrolizumab standard, so it isolates the adjuvant contribution of pembrolizumab in a population that has not had it before surgery, a question KEYNOTE-522 could not answer. The registry lists primary completion in August 2026 and the trial as active, not recruiting; no results were indexed in September 2026. In England the matching NICE appraisal, pembrolizumab as adjuvant treatment after neoadjuvant chemotherapy (GID-TA11724), is awaiting development.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Residual cancer burden (RCB), KEYNOTE-522, Early triple-negative breast cancer.
Shares Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522.
Shares Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522.
Shares Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522, Early triple-negative breast cancer.
Shares Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522.
Shares Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Early triple-negative breast cancer.
Shares SWOG Cancer Research Network, KEYNOTE-522, Early triple-negative breast cancer, Triple-negative breast cancer trials open today (registry snapshot and UK sites).
Shares Early triple-negative breast cancer, Triple-negative breast cancer trials open today (registry snapshot and UK sites), Pembrolizumab, Immune checkpoint inhibitors.
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