# DESTINY-Breast11

Source: https://onco.cc/trials/destiny-breast11/  
OnCo record `destiny-breast11` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

DESTINY-Breast11 brought Enhertu into pre-surgery treatment of HER2-positive breast cancer, replacing anthracyclines.

## Summary

DESTINY-Breast11, trial NCT05113251 sponsored by Daiichi Sankyo and AstraZeneca and reported in 2025, brought trastuzumab deruxtecan into pre-surgery treatment of high-risk HER2-positive early breast cancer, replacing anthracyclines. It randomised 927 patients to trastuzumab deruxtecan followed by a taxane, trastuzumab and pertuzumab, or dose-dense anthracycline chemotherapy followed by the same, met its primary pathologic complete response endpoint with a better tolerated regimen, and led to FDA approval in the second quarter of 2026 alongside DESTINY-Breast05, while the trastuzumab deruxtecan monotherapy arm was stopped early for lower efficacy and event-free survival remains immature. Whether a higher pathologic complete response rate converts into fewer recurrences is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-04
- Registry id: NCT05113251
- Phase: 3
- Setting: Neoadjuvant high-risk HER2+ early breast cancer: T-DXd followed by THP vs ddAC-THP
- Sponsor: Daiichi Sankyo / AstraZeneca
- Enrolled: 927
- Result: pCR 67.3% vs 56.3%.
- Outcomes: Pathologic complete response (ypT0/Tis ypN0): T-DXd → THP 67.3% vs ddAC → THP 56.3%; Event-free survival: T-DXd → THP vs ddAC → THP
- Replication: Single pivotal neoadjuvant trial; pCR is a surrogate. The post-neoadjuvant DESTINY-Breast05 (T-DXd vs T-DM1) is the companion evidence in early HER2+ disease.

## Sources

- ClinicalTrials.gov NCT05113251: https://clinicaltrials.gov/study/NCT05113251

## Connected records

- cancers: [Early HER2-positive breast cancer](https://onco.cc/cancers/her2-positive-early-breast-cancer/), [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- drugs: [Trastuzumab deruxtecan](https://onco.cc/drugs/trastuzumab-deruxtecan/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/), [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/)
- terms: [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/)
- ideas: [Can T-DXd alone cure early HER2-positive disease?](https://onco.cc/ideas/idea-tdxd-first-then-nothing/)
- key papers: [KATHERINE: switching to T-DM1 when HER2-positive breast cancer survives pre-surgery treatment](https://onco.cc/key-papers/paper-katherine-nejm-2019/)
- roadmaps: [Surgery roadmap: radical operations → less surgery → no surgery when a drug has done the work](https://onco.cc/roadmaps/surgery-roadmap/)

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