A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)
Summary
The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in participants with inoperable or metastatic HR-positive, HER2- negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy.
Timeline
- Start
- 2021-10-18
- Primary completion
- 2024-07-24
- Completion
- 2026-07-31
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (superiority test); Dato-DXd vs Investigator's Choice of Chemotherapy (ICC); p <0.0001; Hazard Ratio (HR) 0.63 (99% CI 0.49 to 0.80); Log Rank reads as mixed primary results NCT05104866 ↗
registry analysis (superiority test); Dato-DXd vs Investigator's Choice of Chemotherapy (ICC); p = 0.9445; Hazard Ratio (HR) 1.01 (95.97% CI 0.83 to 1.23); Log Rank reads as mixed primary results NCT05104866 ↗
release “TROPION-Breast01 Phase III trial showed that datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival” reads as mixed primary results astrazeneca.com ↗
release “interim results numerically favoured datopotamab deruxtecan over chemotherapy (HR 0.84; 95% CI 0.62-1.14), however, results did not reach statistical significance” reads as mixed primary results astrazeneca.com ↗
release “Previously presented primary results from TROPION-Breast01 showed datopotamab deruxtecan demonstrated a statistically significant and clinically meaningful improvement in PFS versus investigator’s choice of chemotherapy.” reads as met primary endpoint astrazeneca.com ↗
release “High-level results from the TROPION-Breast01 Phase III trial of datopotamab deruxtecan (Dato-DXd) compared to investigator’s choice of chemotherapy, which previously met the dual primary endpoint” reads as met primary endpoint astrazeneca.com ↗
Publications
- Bardia A, Jhaveri K, Im SA, Pernas S, De Laurentiis M, Wang S, Martinez Janez N, Borges G, Cescon DW, Hattori M, Lu YS, Hamilton E, Zhang Q, Tsurutani J, Kalinsky K, Rubini Liedke PE, Xu L, Fairhurst RM, Khan S, Denduluri N, Rugo HS, Xu B, Pistilli B; TROPION-Breast01 Investigators. Datopotamab Deruxtecan Versus Chemotherapy in Previously Treated Inoperable/Metastatic Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer: Primary Results From TROPION-Breast01. J Clin Oncol. 2025 Jan 20;43(3):285-296. doi: 10.1200/JCO.24.00920. Epub 2024 Sep 12.
- Bardia A, Jhaveri K, Kalinsky K, Pernas S, Tsurutani J, Xu B, Hamilton E, Im SA, Nowecki Z, Sohn J, Laurentiis M, Janez NM, Adamo B, Lee KS, Jung KH, Rubovszky G, Tseng LM, Lu YS, Yuan Y, Maxwell MJ, Haddad V, Khan SS, Rugo HS, Pistilli B. TROPION-Breast01: Datopotamab deruxtecan vs chemotherapy in pre-treated inoperable or metastatic HR+/HER2- breast cancer. Future Oncol. 2024 Mar;20(8):423-436. doi: 10.2217/fon-2023-0188. Epub 2023 Jun 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | — | Oral |
| Subject | Datopotamab deruxtecan | Monoclonal antibody | 6 mg/kg | Intravenous |
| Comparator | Eribulin | Small molecule | — | Intravenous |
| Comparator | Gemcitabine | Small molecule | — | Intravenous |
| Comparator | Vinorelbine | Small molecule | — | Intravenous |