{"entity":{"id":"optimice-pcr","kind":"trial","name":"OptimICE-pCR (A012103)","aka":[],"tldr":"Asks whether patients whose cancer completely disappeared before surgery still need a year of immunotherapy afterwards.","summary":"OptimICE-pCR, Alliance trial A012103, NCT05812807, sponsored by the Alliance and the NCI, asks whether patients with stage II to III triple-negative breast cancer whose cancer completely disappeared before surgery on the KEYNOTE-522 regimen still need a year of adjuvant pembrolizumab afterwards. It is a de-escalation trial of 1,295 patients comparing adjuvant pembrolizumab with observation, and if non-inferior it would spare about sixty percent of KEYNOTE-522 patients nine cycles of immunotherapy; it was discussed at ASCO 2026 and is ongoing with no results. OnCo links it to triple-negative breast cancer, pembrolizumab, the pCR term, the TNBC roadmap, the idea of ctDNA-triggered escalation and the Alliance for Clinical Trials in Oncology. Whether pathologic complete response is a safe enough signal to stop treatment is the question it will answer.","status":"recruiting","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT05812807","url":"https://clinicaltrials.gov/study/NCT05812807"}],"tags":[],"related":[],"cancers":["tnbc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["alliance-oncology"],"institutions":[],"pathways":[],"terms":["pcr"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05812807","phase":"3","setting":"Stage II-III TNBC with pathologic complete response after KEYNOTE-522 regimen: adjuvant pembrolizumab vs observation","sponsor":"Alliance / NCI","started":"2023-06-14","startedType":"actual","enrolled":1295,"enrolledBasis":"registry","outcomes":[],"replication":"Ongoing de-escalation trial; no results."},"route":"/trials/optimice-pcr/","neighbours":{"cancer":[{"id":"tnbc-early","kind":"cancer","name":"Early triple-negative breast cancer","route":"/cancers/tnbc-early/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"alliance-oncology","kind":"company","name":"Alliance for Clinical Trials in Oncology","route":"/companies/alliance-oncology/"}],"term":[{"id":"pcr","kind":"term","name":"Pathologic complete response (pCR)","route":"/terms/pcr/"},{"id":"tnbc-trials-open-today","kind":"term","name":"Triple-negative breast cancer trials open today (registry snapshot and UK sites)","route":"/terms/tnbc-trials-open-today/"}],"paper":[{"id":"paper-asco-pembrolizumab-early-tnbc-rapid-update-jco-2022","kind":"paper","name":"Use of Immune Checkpoint Inhibitor Pembrolizumab in the Treatment of High-Risk, Early-Stage Triple-Negative Breast Cancer: ASCO Guideline Rapid Recommendation Update","route":"/key-papers/paper-asco-pembrolizumab-early-tnbc-rapid-update-jco-2022/"}],"roadmap":[{"id":"tnbc-history","kind":"roadmap","name":"TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line","route":"/roadmaps/tnbc-history/"},{"id":"tnbc-roadmap","kind":"roadmap","name":"Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem","route":"/roadmaps/tnbc-roadmap/"}],"idea":[{"id":"idea-ctdna-escalation-tnbc","kind":"idea","name":"ctDNA-triggered escalation in early TNBC","route":"/ideas/idea-ctdna-escalation-tnbc/"},{"id":"idea-tnbc-de-escalation-for-exceptional-responders","kind":"idea","name":"Give exceptional responders less: pembrolizumab omission after complete response, anthracycline-free regimens and chemotherapy omission in lymphocyte-rich stage I disease","route":"/ideas/idea-tnbc-de-escalation-for-exceptional-responders/"}],"trial":[{"id":"keynote-522","kind":"trial","name":"KEYNOTE-522","route":"/trials/keynote-522/"}]}}