# ASCENT-05 / OptimICE-RD (AFT-65, GBG 119, NSABP B-63)

Source: https://onco.cc/trials/ascent-05/  
OnCo record `ascent-05` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Tests whether giving a TROP2 ADC after surgery can cure more of the triple-negative patients whose cancer survived pre-surgery chemo-immunotherapy.

## Summary

International randomised phase 3 in the highest-risk curable TNBC population: residual disease (non-pCR) after KEYNOTE-522-type neoadjuvant therapy. Primary endpoint invasive disease-free survival. If positive, it would be the first ADC in the curative TNBC setting and the KATHERINE moment for TNBC. Readout is event-driven; our estimate is 2027.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-24
- Registry id: NCT05633654
- Phase: 3
- Setting: Stage II to III TNBC with residual invasive disease after neoadjuvant therapy and surgery: adjuvant sacituzumab govitecan + pembrolizumab vs pembrolizumab ± capecitabine
- Sponsor: Gilead / Alliance Foundation Trials
- Enrolled: 1514
- Replication: Ongoing; no results.

## Notes

- Design paper (Future Oncology 2024): AFT-65/ASCENT-05/OptimICE-RD randomises patients with residual invasive disease after neoadjuvant therapy to sacituzumab govitecan with pembrolizumab or physician's choice of pembrolizumab with or without capecitabine; primary endpoint invasive disease-free survival; registry enrolment 1,514 estimated, primary completion June 2027. UK sites (registry, 10): Hull, University Hospitals Birmingham, Clatterbridge Liverpool, Barts, Guy's, Royal Marsden, the Christie, East and North Hertfordshire (Mount Vernon), Taunton, York.
- Registry status on 24 September 2026: Recruiting (registry record last updated 9 September 2026; primary completion expected June 2027).

## Sources

- ClinicalTrials.gov NCT05633654: https://clinicaltrials.gov/study/NCT05633654
- OptimICE-RD design (Future Oncology 2024): https://pmc.ncbi.nlm.nih.gov/articles/PMC11520537/
- OptimICE-RD design (Future Oncology 2024): https://doi.org/10.1080/14796694.2024.2357534

## Connected records

- ideas: [ADC for residual disease after KEYNOTE-522](https://onco.cc/ideas/idea-post-neoadjuvant-adc/), [ctDNA-guided adjuvant decisions after residual disease: escalate the positive, spare the negative](https://onco.cc/ideas/idea-tnbc-ctdna-guided-adjuvant-decisions/)
- trials: [CREATE-X](https://onco.cc/trials/create-x/), [KEYNOTE-522](https://onco.cc/trials/keynote-522/), [TROPION-Breast03](https://onco.cc/trials/tropion-breast03/)
- cancers: [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/), [Sacituzumab govitecan](https://onco.cc/drugs/sacituzumab-govitecan/)
- terms: [Event-free / disease-free survival (EFS, DFS, iDFS, RFS)](https://onco.cc/terms/efs/), [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/), [Residual cancer burden (RCB)](https://onco.cc/terms/rcb/), [Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point](https://onco.cc/terms/tnbc-residual-disease-decision/), [Triple-negative breast cancer trials open today (registry snapshot and UK sites)](https://onco.cc/terms/tnbc-trials-open-today/)
- key papers: [Long-Term Prognostic Risk After Neoadjuvant Chemotherapy Associated With Residual Cancer Burden and Breast Cancer Subtype](https://onco.cc/key-papers/paper-symmans-rcb-long-term-prognosis-subtype-jco-2017/)
- roadmaps: [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/)

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