TROPION-Breast01: NCT05104866: Phase 3: Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer, treated With 1-2 Prior LOT

First Posted	2021-11-03
Trial status	Active, not recruiting
Sponsor	AstraZeneca
Abstract Presentation	ESMO 2023 (Annals of Oncology) abstract (LBA11) LBA11 Datopotamab deruxtecan (Dato-DXd) vs chemotherapy in previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer (BC): Primary results from the randomised phase III TROPION-Breast01 trial October 2023 Click here for details AACR 2024 (Cancer Research) abstract (GS02-01) Abstract GS02-01: Randomized phase 3 study of datopotamab deruxtecan vs chemotherapy for patients with previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative breast cancer: Results from TROPION-Breast01 May 02 2024 Click here for details
Peer-reviewed journal publication	Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone-receptor-positive HER2-negative breast cancer: final overall survival analysis of the phase 3 TROPION-Breast01 study Ann Oncol. 2025 Dec 23 Click here for details 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 Click here for details
FDA	FDA Approved. FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer January 17, 2025 Click here for details
Press Release	Datopotamab deruxtecan final overall survival results reported in patients with metastatic HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial 23 September 2024 Click here for details
NCCN	NCCN Supported. BRS201

TROPION-Breast01: NCT05104866: Phase 3: Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer, treated With One or Two Prior Lines

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)

Official Title:

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)

Intervention / Treatment:

Drug: Dato-DXd

Drug: Capecitabine

Drug: Gemcitabine

Drug: Eribulin

Drug: Vinorelbine

Other Study ID Numbers:

D9268C00001

2023-509631-37-00 ( Registry Identifier ) (REGISTRY: CTIS (EU))

2020-005620-12 ( EudraCT Number )

ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT05104866