Overview

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 System

Status:
Recruiting

Trial end date:
2025-07-21

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

AstraZeneca

Collaborator:

Daiichi Sankyo, Inc.

Treatments:

Capecitabine
Gemcitabine
Vinorelbine