TROPION-Breast02
The first trial to show an overall survival benefit for a first-line ADC in triple-negative breast cancer.
Dual primary endpoints of PFS and OS both met (OS 23.7 vs 18.7 months per patient summaries; ESMO 2025 / ESMO Breast 2026). FDA approval Q2 2026. Head-to-head with ASCENT-03 (sacituzumab) is indirect; choice is patient-dependent (stomatitis/ocular vs neutropenia/diarrhoea).
- Median 10.8 vs 5.6 months with Datopotamab deruxtecan compared with Chemotherapy (ICC); about 5.2 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 43 percent lower chance of the event at any given time (hazard ratio 0.57, likely range 0.47 to 0.69).
- 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 23.7 vs 18.7 months with Datopotamab deruxtecan compared with Chemotherapy (ICC); about 5 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 21 percent lower chance of the event at any given time (hazard ratio 0.79, likely range 0.64 to 0.98).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: First-line metastatic TNBC, not candidates for PD-1/PD-L1: Dato-DXd vs chemotherapy. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (PD-1); 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.
644 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (BICR)primary | Datopotamab deruxtecan | 323 | 10.8 months | 0.57 (0.47–0.69) | <0.0001 | link |
| Chemotherapy (ICC) | 321 | 5.6 months | ||||
| Overall survivalprimary | Datopotamab deruxtecan | — | 23.7 months | 0.79 (0.64–0.98) | 0.0291 | link |
| Chemotherapy (ICC) | — | 18.7 months |
Pages like this
not linked directly; found by shared links- TrialTROPION-Breast05
Shares TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Datopotamab deruxtecan, Triple-negative breast cancer (TNBC).
- TrialTROPION-Breast01
Shares TROPION-Breast01: datopotamab deruxtecan versus chemotherapy in pretreated hormone-receptor-positive breast cancer, and why a PFS win did not translate to survival, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Datopotamab deruxtecan.
- TrialASCENT-03
Shares TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Triple-negative breast cancer (TNBC).
- TrialASCENT
Shares TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Triple-negative breast cancer (TNBC).
- TrialIZABRIGHT-Breast01
Shares TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, Triple-negative breast cancer (TNBC).
- TrialASCENT-04 / KEYNOTE-D19
Shares TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Triple-negative breast cancer (TNBC).
- PairingCaution: TOP1 ADC immediately after TOP1 ADC
Shares TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Datopotamab deruxtecan, Triple-negative breast cancer (TNBC).
- IdeaTROP2 PET to choose and sequence TROP2 ADCs
Shares TROPION-Breast01: datopotamab deruxtecan versus chemotherapy in pretreated hormone-receptor-positive breast cancer, and why a PFS win did not translate to survival, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Datopotamab deruxtecan, Triple-negative breast cancer (TNBC).