Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05646862
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2022-12-02
Brief Title:
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive HER2-Negative PIK3CA Mutated Locally Advanced or Metastatic Breast Cancer Post CDK46i and Endocrine Combination Therapy
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase III Multicenter Randomized Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive HER2-Negative PIK3CA Mutated Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK46 Inhibitor and Endocrine Combination Therapy
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INAVO121
Brief Summary:
This is a Phase III multicenter randomized open-label global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor HR-positive human epidermal growth factor receptor 2 HER2 -negative PIK3CA-mutated locally advanced LA or metastatic breast cancer mBC who progressed during or after cyclin dependent kinase 46i CDK46i-based therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-502322-41-00 | REGISTRY | EU Clinical Trials | None |