Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2025-12-26 @ 8:33 AM
Study NCT ID:
NCT05104866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-14
First Post:
2021-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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)
Sponsor:
AstraZeneca
Organization:
Key Dates - Follows AllAPIJSON File Order
Start Date:
2021-10-18
Start Date Type:
ACTUAL
Primary Completion Date:
2024-07-24
Primary Completion Date Type:
ACTUAL
Completion Date:
2025-12-31
Completion Date Type:
ESTIMATED
First Submit Date:
2021-10-04
First Submit QC Date:
None
Study First Post Date:
2021-11-03
Study First Post Date Type:
ACTUAL
Results First Submit Date:
None
Results First Submit QC Date:
None
Results First Post Date:
None
Results First Post Date Type:
None
Results First Post QC Date:
None
Results First Post QC Date Type:
None
Disp First Submit Date:
None
Disp First Submit QC Date:
None
Disp First Post Date:
None
Disp First Post Date Type:
None
Last Update Submit Date:
2025-04-11
Last Update Post Date:
2025-04-14
Last Update Post Date Type:
ACTUAL