Clinical Trial: NCT05104866
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)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-08-24 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Dato-DXd
- Drug: Capecitabine
- Drug: Gemcitabine
- Drug: Eribulin
- Drug: Vinorelbine
Other Study ID Numbers
- D9268C00001
- 2023-509631-37-00
- 2020-005620-12
- 2023
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Estimated)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-08-24 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Dato-DXd
- Drug: Capecitabine
- Drug: Gemcitabine
- Drug: Eribulin
- Drug: Vinorelbine
Other Study ID Numbers
- D9268C00001
- 2023-509631-37-00
- 2020-005620-12
- 2023