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The first trial to show an overall survival benefit for a first-line ADC in triple-negative breast cancer.
TROPION-Breast02, trial NCT05374512 sponsored by AstraZeneca and Daiichi Sankyo and reported at ESMO 2025 and ESMO Breast 2026, was the first trial to show an overall survival benefit for a first-line antibody-drug conjugate in metastatic triple-negative breast cancer, in patients who cannot receive PD-1 or PD-L1 inhibitors. It randomised 644 patients to datopotamab deruxtecan or chemotherapy, met both dual primary endpoints of progression-free and overall survival, and led to FDA approval in the second quarter of 2026. OnCo links it to triple-negative breast cancer, datopotamab deruxtecan, Rebecca Dent, the TNBC and TROP2 ADC roadmaps and the TROPION-Breast01 paper. The comparison with sacituzumab is indirect, so choice depends on side-effect profiles, stomatitis and eye effects against neutropenia and diarrhoea, which is the open question.
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 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 to 0.69) | <0.0001 | link |
| Chemotherapy (ICC) | 321 | 5.6 months | ||||
| Overall survivalprimary | Datopotamab deruxtecan | - | 23.7 months | 0.79 (0.64 to 0.98) | 0.0291 | link |
| Chemotherapy (ICC) | - | 18.7 months |
NCCN is the source of the category grades on the triple-negative breast cancer page and the first major guideline to place an antibody-drug conjugate first line for the disease.
The first-line overall survival result that made an antibody-drug conjugate the standard for PD-L1-negative or immunotherapy-ineligible metastatic triple-negative disease, and the reason the sequencing question (which TROP2 drug first, what after it) is now urgent.
For hormone-receptor-positive metastatic breast cancer that has already had chemotherapy, Dato-DXd controls the disease for longer with fewer severe side effects than chemotherapy, but does not help patients live longer, so it is not a standard option here. The result is a reminder that progression-free survival is a surrogate; regulators and clinicians should wait for survival data before adopting an ADC in a setting where later therapies are effective.
Shares DIAMOND, Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET.
Shares Breast Cancer, Version 4.2026, NCCN Clinical Practice Guidelines In Oncology, Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial, TROP2 PET to choose and sequence TROP2 ADCs, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line.
Shares Breast Cancer, Version 4.2026, NCCN Clinical Practice Guidelines In Oncology, TROP2 PET to choose and sequence TROP2 ADCs, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET.
Shares TROP2 PET to choose and sequence TROP2 ADCs, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, A randomised trial of antibody-drug conjugate sequence in metastatic triple-negative breast cancer.
Shares Datopotamab deruxtecan, Daiichi Sankyo, Metastatic triple-negative breast cancer, Topoisomerase-I inhibitors (and ADC payloads).
Shares TROP2 PET to choose and sequence TROP2 ADCs, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Datopotamab deruxtecan, Daiichi Sankyo.
Shares TROP2 PET to choose and sequence TROP2 ADCs, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, A randomised trial of antibody-drug conjugate sequence in metastatic triple-negative breast cancer.
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, Daiichi Sankyo.