# OptimICE-pCR (A012103)

Source: https://onco.cc/trials/optimice-pcr/  
OnCo record `optimice-pcr` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-04
- Registry id: NCT05812807
- Phase: 3
- Setting: Stage II-III TNBC with pathologic complete response after KEYNOTE-522 regimen: adjuvant pembrolizumab vs observation
- Sponsor: Alliance / NCI
- Enrolled: 1295
- Replication: Ongoing de-escalation trial; no results.

## Sources

- ClinicalTrials.gov NCT05812807: https://clinicaltrials.gov/study/NCT05812807

## Connected records

- cancers: [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Alliance for Clinical Trials in Oncology](https://onco.cc/companies/alliance-oncology/)
- terms: [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/), [Triple-negative breast cancer trials open today (registry snapshot and UK sites)](https://onco.cc/terms/tnbc-trials-open-today/)
- key papers: [Use of Immune Checkpoint Inhibitor Pembrolizumab in the Treatment of High-Risk, Early-Stage Triple-Negative Breast Cancer: ASCO Guideline Rapid Recommendation Update](https://onco.cc/key-papers/paper-asco-pembrolizumab-early-tnbc-rapid-update-jco-2022/)
- roadmaps: [TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line](https://onco.cc/roadmaps/tnbc-history/), [Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem](https://onco.cc/roadmaps/tnbc-roadmap/)
- ideas: [ctDNA-triggered escalation in early TNBC](https://onco.cc/ideas/idea-ctdna-escalation-tnbc/), [Give exceptional responders less: pembrolizumab omission after complete response, anthracycline-free regimens and chemotherapy omission in lymphocyte-rich stage I disease](https://onco.cc/ideas/idea-tnbc-de-escalation-for-exceptional-responders/)
- trials: [KEYNOTE-522](https://onco.cc/trials/keynote-522/)

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