Design Module
The Design Module contains detailed information about the study design, including study type, allocation methods, intervention models, masking information, primary purpose, enrollment details, and biospecimen information. This module provides essential details about how the clinical trial is structured and conducted.
Design Module path is as follows:
Study -> Protocol Section -> Design Module
Design Module
Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2025-12-24 @ 4:30 PM
NCT ID:
NCT05104866
Study Type:
INTERVENTIONAL
Allocation:
RANDOMIZED
Primary Purpose:
TREATMENT
Study:
NCT05104866
Study Brief:
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)
Protocol Section:
NCT05104866
Bio Specs (If Any):
Design Masking Infos (If Any):
Design Masking Infos
| Design Masking Brief | View |
|---|---|
| None | View |
Design Observational Models (If Any):
Design Time Perspectives (If Any):
Design Who Masked (If Any):
Enrollment Infos (If Any):
Enrollment Infos
| Enrollment Type | Enrollment Count | View |
|---|---|---|
| ACTUAL | 732 | View |
Expanded Access Types (If Any):
Phases (If Any):
Phases
| Phase Brief | Phase Text | View |
|---|---|---|
| None | PHASE3 | View |