DESTINY-Breast12
Enhertu shrank brain metastases in most patients, including those with untreated lesions, answering a question its earlier trials had excluded.
Phase 3b/4, 263 patients with brain metastases: 12-month PFS 61.6%; CNS ORR 71.7% overall (82.6% in active/untreated brain metastases). Supports T-DXd as a systemic option for brain metastases rather than local therapy first in selected patients.
Setting
HER2+ metastatic breast cancer with or without brain metastases: single-arm T-DXd
Phase
Phase 3
Sponsor
AstraZeneca / Daiichi Sankyo
Registry
Headline result
CNS ORR 71.7%; 12-month PFS 61.6% in brain-metastasis cohort.
Reported
2024
Enrolled
504
Replication
Consistent with DEBBRAH and TUXEDO phase 2 studies of T-DXd in brain metastases.
In plain words
What these results mean for people, not percentages
Intracranial objective response rateprimaryresponse endpoint
- 71.7 out of 100 people had their tumour shrink with T-DXd (brain metastasis cohort).
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: HER2+ metastatic breast cancer with or without brain metastases: single-arm T-DXd. 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.
504 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Intracranial objective response rateprimary | T-DXd (brain metastasis cohort) | 263 | 71.7% | — | — | link |
Replication
Consistent with DEBBRAH and TUXEDO phase 2 studies of T-DXd in brain metastases.