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 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT05631795
Study Type:
INTERVENTIONAL
Allocation:
NA
Primary Purpose:
TREATMENT
Study:
NCT05631795
Study Brief:
Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
Protocol Section:
NCT05631795
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 | 40 | View |
Expanded Access Types (If Any):
Phases (If Any):
Phases
| Phase Brief | Phase Text | View |
|---|---|---|
| None | PHASE4 | View |