At a glance
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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)
In Brief
A Phase 3 clinical trial evaluating Dato-DXd, Capecitabine, and 3 other interventions for Breast Cancer. Active but no longer recruiting, targeting 732 participants across 167 sites in 20 countries.
Detailed 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.
Study Details
Timeline
Interventions
Experimental drug. Provided in 100mg vials. IV infusion.
Tablet. Oral route of administration. Active comparator
IV Infusion. Active comparator
IV Infusion. Active comparator
IV Infusion. Active comparator