Ignite Creation Date:
2024-05-06 @ 2:43 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04408118
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2020-05-20
Brief Title:
First Line Atezolizumab Paclitaxel and Bevacizumab Avastin in mTNBC
Sponsor:
MedSIR
Organization:
MedSIR
Study Overview
Official Title:
Phase II Clinical Trial to Evaluate the Efficacy and Safety of First Line Atezolizumab in Combination With Paclitaxel and Bevacizumab Avastin in Patients With Advanced or Metastatic Triple-negative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2023-12
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:
ATRACTIB
Brief Summary:
This is a multicenter open-label single-arm phase II clinical trial to evaluate to evaluate the efficacy and safety of first line atezolizumab in combination with paclitaxel and bevacizumab Avastin in patients with advanced or metastatic triple-negative breast cancer mTNBC
Detailed Description:
Men and women age 18 years with previously untreated unresectable locally advanced or metastatic triple-negative breast cancer TNBC that is not amenable to resection with curative intent regardless of programmed death-ligand 1 PD-L1 status
The number of patients to be included is 100 patients The primary objective is to evaluate the efficacy -in terms of progression-free survival PFS- of first line atezolizumab in combination with paclitaxel and bevacizumab Avastin in patients with unresectable locally advanced or metastatic TNBC
After signing the ICF and confirmed eligibility patients will begin treatment on 28 days cycles Atezolizumab 840 mg intravenously on days 1 and 15 Paclitaxel 90 mgm2 via IV infusion on days 1 8 and 15 Bevacizumab Avastin 10mgkg intravenously on days 1 and 15
Patients will receive treatment until disease progression unacceptable toxicity death or discontinuation from the study treatment for any other reason
Patients discontinuing the study treatment will enter a post- treatment follow-up period until death withdrawal of consent patient is lost to follow-up or study termination
The number of patients to be included is 100 patients The primary objective is to evaluate the efficacy -in terms of progression-free survival PFS- of first line atezolizumab in combination with paclitaxel and bevacizumab Avastin in patients with unresectable locally advanced or metastatic TNBC
After signing the ICF and confirmed eligibility patients will begin treatment on 28 days cycles Atezolizumab 840 mg intravenously on days 1 and 15 Paclitaxel 90 mgm2 via IV infusion on days 1 8 and 15 Bevacizumab Avastin 10mgkg intravenously on days 1 and 15
Patients will receive treatment until disease progression unacceptable toxicity death or discontinuation from the study treatment for any other reason
Patients discontinuing the study treatment will enter a post- treatment follow-up period until death withdrawal of consent patient is lost to follow-up or study termination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| 2019-001503-20 | EUDRACT_NUMBER | None | None |