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Asks whether patients whose cancer completely disappeared before surgery still need a year of immunotherapy afterwards.
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.
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 Give exceptional responders less: pembrolizumab omission after complete response, anthracycline-free regimens and chemotherapy omission in lymphocyte-rich stage I disease, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, KEYNOTE-522, Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem.
Shares KEYNOTE-522, Pathologic complete response (pCR), UCSF Helen Diller Family Comprehensive Cancer Center, Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem.
Shares Give exceptional responders less: pembrolizumab omission after complete response, anthracycline-free regimens and chemotherapy omission in lymphocyte-rich stage I disease, KEYNOTE-522, Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem.
Shares Early triple-negative breast cancer, Triple-negative breast cancer trials open today (registry snapshot and UK sites), Pembrolizumab, Immune checkpoint inhibitors.
Shares Early triple-negative breast cancer, Triple-negative breast cancer trials open today (registry snapshot and UK sites), Pembrolizumab, Immune checkpoint inhibitors.
Shares KEYNOTE-522, Early triple-negative breast cancer, Triple-negative breast cancer trials open today (registry snapshot and UK sites), Triple-negative breast cancer (TNBC).
Shares KEYNOTE-522, Pathologic complete response (pCR), Early triple-negative breast cancer, Triple-negative breast cancer (TNBC).
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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