Study identifier:D9268C00001
ClinicalTrials.gov identifier:NCT05104866
EudraCT identifier:2020-005620-12
CTIS identifier:N/A
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)
Breast Cancer
Phase 3
No
Dato-DXd, Capecitabine, Gemcitabine, Eribulin, Vinorelbine
All
732
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
Daiichi Sankyo
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Dato-DXd Arm 1: Dato-DXd | Drug: Dato-DXd Experimental drug. Provided in 100mg vials. IV infusion. Other Name: Datopotamab deruxtecan (Dato-DXd, DS-1062a) |
Active Comparator: Investigators Choice of Chemotherapy (ICC) Arm 2: ICC Capecitabine Gemcitabine Eribulin mesylate Vinorelbine | Drug: Capecitabine Tablet. Oral route of administration. Active comparator Drug: Gemcitabine IV Infusion. Active comparator Drug: Eribulin IV Infusion. Active comparator Other Name: Eribulin Mesylate Drug: Vinorelbine IV Infusion. Active comparator |