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)

Study identifier:D9268C00001

ClinicalTrials.gov identifier:NCT05104866

EudraCT identifier:2020-005620-12

CTIS identifier:N/A

Recruitment Complete

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)

Medical condition

Breast Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Dato-DXd, Capecitabine, Gemcitabine, Eribulin, Vinorelbine

Sex

All

Actual Enrollment

732

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 18 Oct 2021
Estimated Primary Completion Date: 15 Aug 2025
Estimated Study Completion Date: 15 Aug 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi Sankyo

Inclusion and exclusion criteria