Ignite Creation Date:
2024-05-06 @ 12:36 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03800836
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2019-01-07
Brief Title:
A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase Ib Open-Label Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2022-04
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:
None
Brief Summary:
This is a study consisting of four cohorts in this setting In Cohort 1 the safety and efficacy of ipatasertib ipat in combination with atezolizumab atezo and paclitaxel pac or nab-paclitaxel will be evaluated for participants with locally advanced or metastatic triple-negative breast cancer TNBC who have not previously received chemotherapy In Cohort 2 ipatasertib and atezolizumab with no chemotherapy will be administered to participants with locally advanced or metastatic TNBC In Cohort 3 the safety and efficacy of neoadjuvant ipatasertib atezolizumab doxorubicin and cyclophosphamide AC Ipat Atezo AC followed by Ipat Atezo Pac will be evaluated in participants with locally advanced Type 2-4 T2-4 TNBC In Cohort 4 the safety and efficacy of Ipat Atezo Pac will be evaluated in participants with PD-L1 Programmed Death-Ligand-1 positive locally advanced or metastatic TNBC that is not amenable to resection and who have not previously received chemotherapy in the advanced setting
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 |
|---|---|---|---|
| 2017-001957-15 | EUDRACT_NUMBER | None | None |