DESTINY-Breast11
DESTINY-Breast11 brought Enhertu into pre-surgery treatment of HER2-positive breast cancer, replacing anthracyclines.
pCR 67.3% vs 56.3%; better tolerated than anthracycline-containing control. FDA approval Q2 2026 alongside DESTINY-Breast05 (post-neoadjuvant residual disease, T-DXd beat T-DM1).
Setting
Neoadjuvant high-risk HER2+ early breast cancer: T-DXd followed by THP vs ddAC-THP
Phase
Phase 3
Sponsor
Daiichi Sankyo / AstraZeneca
Registry
Headline result
pCR 67.3% vs 56.3%.
Reported
2025
Enrolled
927
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.
In plain words
What these results mean for people, not percentages
Pathologic complete response (ypT0/Tis ypN0)primarysurrogate endpoint
- 67.3 vs 56.3 out of 100 had no cancer left at surgery with T-DXd → THP compared with ddAC → THP; 11 more per 100.
- Roughly one extra person helped for every 9 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.003) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
Event-free survivalsurrogate endpoint
- Numbers are not recorded here for this endpoint. T-DXd → THP: Immature; the T-DXd monotherapy arm was stopped early for lower efficacy.; ddAC → THP.
- Immature; the T-DXd monotherapy arm was stopped early for lower efficacy.
Be careful
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Neoadjuvant high-risk HER2+ early breast cancer: T-DXd followed by THP vs ddAC-THP. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (HER2); the result should not be assumed for people whose cancer does not have it.
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 participants enrolled.
Pathologic complete response (ypT0/Tis ypN0)primary
· p = 0.003
T-DXd → THP67.3 of 100
n = 321
ddAC → THP56.3 of 100
n = 320
Event-free survival
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 | — | — |
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.