TROPION-Breast01
The trial that got Datroway approved in hormone-positive breast cancer, though it did not extend overall survival.
PFS 6.9 vs 4.9 months (HR 0.63); OS not significantly different (HR 1.01). Approved January 2025 in the US on PFS.
- Median 6.9 vs 4.9 months with Datopotamab deruxtecan compared with Chemotherapy (ICC); about 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 37 percent lower chance of the event at any given time (hazard ratio 0.63, likely range 0.52 to 0.76).
- 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 18.6 vs 18.3 months with Datopotamab deruxtecan compared with Chemotherapy (ICC); about 0.3 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 1 percent higher chance of the event at any given time (hazard ratio 1.01, likely range 0.83 to 1.22).
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- Not significant.
- 36.4 vs 22.9 out of 100 had their tumour shrink with Datopotamab deruxtecan compared with Chemotherapy (ICC); 13.5 more per 100.
- Roughly one extra person helped for every 7 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- 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: HR+/HER2- metastatic breast cancer after endocrine and 1-2 chemotherapies: Dato-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.
732 participants enrolled.
Not significant
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (BICR)primary | Datopotamab deruxtecan | 365 | 6.9 months | 0.63 (0.52–0.76) | <0.0001 | link |
| Chemotherapy (ICC) | 367 | 4.9 months | ||||
| Overall survivalprimary | Datopotamab deruxtecan | — | 18.6 months | 1.01 (0.83–1.22) | — | link |
| Chemotherapy (ICC) | — | 18.3 months | ||||
| Objective response rate | Datopotamab deruxtecan | — | 36.4% | — | — | — |
| Chemotherapy (ICC) | — | 22.9% |
Pages like this
not linked directly; found by shared links- TrialTROPION-Breast02
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.
- PairingCaution: TOP1 ADC immediately after TOP1 ADC
Shares TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Datopotamab deruxtecan, HR-positive / HER2-negative breast cancer.
- TrialTROPION-Lung01
Shares TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Datopotamab deruxtecan.
- TrialTROPION-Breast05
Shares TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Datopotamab deruxtecan.
- 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.
- PairingTROP2 PET → TROP2 ADC selection
Shares TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Datopotamab deruxtecan.
- PersonJoohyuk Sohn
Shares Datopotamab deruxtecan, HR-positive / HER2-negative breast cancer.
- PersonSeock-Ah Im
Shares TROPION-Breast01: datopotamab deruxtecan versus chemotherapy in pretreated hormone-receptor-positive breast cancer, and why a PFS win did not translate to survival, HR-positive / HER2-negative breast cancer.