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).
- 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.
- 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.
- 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.
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 | — | — |
Pages like this
not linked directly; found by shared links- TrialDESTINY-Breast05
Shares Can T-DXd alone cure early HER2-positive disease?, Trastuzumab deruxtecan, HER2-positive breast cancer.
- TrialPHERGain
Shares Can T-DXd alone cure early HER2-positive disease?, Pathologic complete response (pCR), HER2-positive breast cancer.
- PersonSibylle Loibl
Shares KATHERINE: switching to T-DM1 when HER2-positive breast cancer survives pre-surgery treatment, Pathologic complete response (pCR), HER2-positive breast cancer.
- PersonGunter von Minckwitz
Shares KATHERINE: switching to T-DM1 when HER2-positive breast cancer survives pre-surgery treatment, HER2-positive breast cancer.
- ProductTrastuzumab duocarmazine
- TrialDESTINY-Breast03
Shares KATHERINE: switching to T-DM1 when HER2-positive breast cancer survives pre-surgery treatment, Trastuzumab deruxtecan, HER2-positive breast cancer.
- TrialDESTINY-Breast12
- PersonKan Yonemori