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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 randomized 644 patients (323/321) with previously untreated advanced TNBC for whom PD-1/PD-L1 inhibitor therapy was unsuitable. FDA reports median PFS 10.8 versus 5.6 months (HR 0.57, 95% CI 0.47 to 0.69) and OS 23.7 versus 18.7 months (HR 0.79, 95% CI 0.64 to 0.98). FDA approved the advanced-disease indication May 22, 2026. These outcomes do not establish postoperative benefit or provide a head-to-head comparison against sacituzumab govitecan.
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 randomised.
95% CI 58 to 69 · 95% CI 25 to 36
Source| 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 | 321 | 5.6 months | ||||
| Overall survivalprimary | Datopotamab deruxtecan | 323 | 23.7 months | 0.79 (0.64 to 0.98) | 0.0290 | link |
| Chemotherapy | 321 | 18.7 months | ||||
| Confirmed objective response rate (FDA approval analysis) | Datopotamab deruxtecan | - | 64% | - | - | link |
| Chemotherapy | - | 30% |
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
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 unresectable or metastatic hormone-receptor-positive, HER2-negative breast cancer after endocrine-based therapy and chemotherapy for advanced disease, Dato-DXd is an FDA-approved option. TROPION-Breast01 showed longer progression-free survival and fewer severe treatment-related adverse events than chemotherapy; the final overall survival analysis did not show a statistically significant improvement. Approval in this setting does not establish a survival advantage or apply to postoperative early-stage disease.
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 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, 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 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.
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.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/