DESTINY-Breast04
Created a new category of breast cancer, HER2-low, by showing Enhertu works in tumours previously called HER2-negative.
OS 23.4 vs 16.8 months (HR 0.64). Standing ovation at ASCO 2022. Roughly half of all breast cancers became eligible for a HER2-directed drug overnight.
- Median 10.1 vs 5.4 months with Trastuzumab deruxtecan compared with Chemotherapy (TPC); about 4.7 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 49 percent lower chance of the event at any given time (hazard ratio 0.51, likely range 0.4 to 0.64).
- 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.
- Median 23.4 vs 16.8 months with Trastuzumab deruxtecan compared with Chemotherapy (TPC); about 6.6 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 36 percent lower chance of the event at any given time (hazard ratio 0.64, likely range 0.49 to 0.84).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- Median 8.5 vs 2.9 months with Trastuzumab deruxtecan compared with Chemotherapy (TPC); about 5.6 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 54 percent lower chance of the event at any given time (hazard ratio 0.46, likely range 0.24 to 0.89).
- 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.
- Exploratory cohort.
- These results apply to the people the trial enrolled: HER2-low metastatic breast cancer after chemotherapy: T-DXd vs chemotherapy. 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.
557 participants enrolled.
Exploratory cohort
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival, HR+ cohort (BICR)primary | Trastuzumab deruxtecan | 331 | 10.1 months | 0.51 (0.4–0.64) | <0.001 | link |
| Chemotherapy (TPC) | 163 | 5.4 months | ||||
| Overall survival, all patients | Trastuzumab deruxtecan | 373 | 23.4 months | 0.64 (0.49–0.84) | 0.001 | link |
| Chemotherapy (TPC) | 184 | 16.8 months | ||||
| Progression-free survival, HR-negative (TNBC) cohort | Trastuzumab deruxtecan | 40 | 8.5 months | 0.46 (0.24–0.89) | — | link |
| Chemotherapy (TPC) | 18 | 2.9 months |
Pages like this
not linked directly; found by shared links- TrialDESTINY-Breast06
Shares HER2-low scoring → T-DXd, Calibrated reference slides so every lab scores HER2-low the same way, HER2-low and HER2-ultralow, Trastuzumab deruxtecan.
- IdeaAI quantification of HER2-low and HER2-ultralow
Shares HER2-low scoring → T-DXd, Calibrated reference slides so every lab scores HER2-low the same way, HER2-low and HER2-ultralow, Trastuzumab deruxtecan.
- TrialBL-B01D1-307
Shares TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs, Triple-negative breast cancer (TNBC).
- IdeaRandomised trials to test whether biomarker-negative patients really do not benefit
Shares HER2-low and HER2-ultralow, Trastuzumab deruxtecan, Biomarkers are not validated or standardised.
- PersonGiuseppe Curigliano
Shares HER2-low and HER2-ultralow, Trastuzumab deruxtecan, Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer.
- TrialASCENT-04 / KEYNOTE-D19
Shares TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs, Triple-negative breast cancer (TNBC).
- TechnologyTROP2 PET
Shares TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs, Biomarkers are not validated or standardised, Triple-negative breast cancer (TNBC).
- PersonSung-Bae Kim
Shares DESTINY-Breast04: trastuzumab deruxtecan works in HER2-low breast cancer, creating a new treatable group, Trastuzumab deruxtecan, Triple-negative breast cancer (TNBC).