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DESTINY-Breast11 brought Enhertu into pre-surgery treatment of HER2-positive breast cancer, replacing anthracyclines.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
927 enrolled.
Immature; the T-DXd monotherapy arm was stopped early for lower efficacy.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Pathologic complete response (ypT0/Tis ypN0)primary | T-DXd → THP | 321 | 67.3% | - | 0.003 | link |
| ddAC → THP | 320 | 56.3% | ||||
| Event-free survival | T-DXd → THP | - | Immature; the T-DXd monotherapy arm was stopped early for lower efficacy. | - | - | - |
| ddAC → THP | - | - |
Shares Can T-DXd alone cure early HER2-positive disease?, Early HER2-positive breast cancer, Daiichi Sankyo, Trastuzumab deruxtecan.
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), Antibody-drug conjugate (ADC).
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), Antibody-drug conjugate (ADC).
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Early HER2-positive breast cancer, Topoisomerase-I inhibitors (and ADC payloads), HER2-positive breast cancer, Antibody-drug conjugate (ADC).