Ignite Creation Date:
2024-05-06 @ 10:13 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03197935
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2017-06-21
Brief Title:
A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab Anti-PD-L1 Antibody in Combination With Neoadjuvant AnthracyclineNab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2023-10
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:
IMpassion031
Brief Summary:
This is a global Phase III double-blind randomized placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab anti-programmed death-ligand 1 anti-PD-L1 antibody and nab-paclitaxel followed by doxorubicin and cyclophosphamide nab-pac-AC or placebo and nab-pac-AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer TNBC
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 |
|---|---|---|---|
| 2016-004734-22 | EUDRACT_NUMBER | None | None |