Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer: results from the TROPION-Breast01 China cohort
In brief
Datopotamab deruxtecan more than doubles PFS to 8.1 months vs 4.2 months
In 83 Chinese patients with previously treated metastatic HR-positive/HER2-negative breast cancer, the antibody-drug conjugate extended median progression-free survival to 8.1 months compared with 4.2 months on standard chemotherapy, while severe treatment-related side effects occurred in about 30% versus 58% with chemo. The results support Dato-DXd as a viable new option, though overall survival benefit remains unproven.
- Journal
- ESMO open (Q1)
- Published
- 11 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- S Wang, Q Zhang, Z Jiang, Z Tong, W Li, J Wang, et al.
- PMID
- 42727418
- DOI
- 10.1016/j.esmoop.2026.108538
Why clinicians should know about it
- Picked for Oncology and Radiation Oncology (paper of the day, 14 September 2026): Phase III RCT of datopotamab‑deruxtecan vs chemo
- Picked for Surgical Oncology (top studies of the week, 13 September 2026): Datopotamab deruxtecan versus chemotherapy in HR+/HER2‑ breast cancer: China cohort
- Picked for Radiation Oncology (top studies of the week, 13 September 2026): Datopotamab deruxtecan vs chemo, systemic therapy
Abstract
BACKGROUND: In the global phase III TROPION-Breast01 study, datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by blinded independent central review (BICR) versus investigator's choice of chemotherapy (ICC) in patients with previously treated, inoperable/metastatic hormone receptor(HR)-positive human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. At the final analysis, overall survival (OS) was not statistically significant. We report final results from the prespecified analysis of patients enrolled in mainland China. PATIENTS AND METHODS: Patients with inoperable/metastatic HR+/HER2- breast cancer, who had disease progression on endocrine therapy and for whom endocrine therapy was unsuitable and who had received 1-2 prior lines of chemotherapy in the inoperable/metastatic setting, were randomly assigned 1 : 1 to Dato-DXd (6 mg/kg every 3 weeks) or ICC (eribulin/capecitabine/vinorelbine/gemcitabine). Dual primary endpoints were PFS by BICR and OS. RESULTS: Overall, 83 patients were enrolled in mainland China (Dato-DXd, n = 44; ICC, n = 39). PFS by BICR numerically favored Dato-DXd versus ICC [hazard ratio (HR) 0.54, 95% confidence interval (CI) 0.30-0.96, nominal P = 0.0329; median PFS: 8.1 versus 4.2 months]. OS numerically favored Dato-DXd versus ICC [HR 0.83 (95% CI 0.49-1.43), nominal P = 0.5028]. The rate of grade ≥3 treatment-related adverse events (TRAEs) was lower with Dato-DXd versus ICC (29.5% versus 58.3%). The most common TRAEs (any grade/grade 3-4) were nausea (47.7%/4.5%) and increased aspartate aminotransferase (40.9%/2.3%) with Dato-DXd, and neutropenia (grouped term, 58.3%/36.1%) and anemia (52.8%/8.3%) with ICC. With Dato-DXd, treatment-related AEs of special interest (grouped terms) oral mucositis/stomatitis and ocular surface events occurred in 43.2% and 47.7% of patients, respectively. CONCLUSION: In this China cohort, Dato-DXd demonstrated numerically improved efficacy versus ICC and a manageable safety profile, consistent with the global population, supporting Dato-DXd as a new treatment option for Chinese patients with previously treated metastatic HR+/HER2- breast cancer.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.