Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04690855
Status:
TERMINATED
Last Update Posted:
2023-12-04
First Post:
2020-12-28
Brief Title:
A Study to Evaluate TAlazoparib Radiotherapy and Atezolizumab in gBRCA 12 Negative Patients With PD-L1 Metastatic Triple Negative Breast Cancer
Sponsor:
Mylin A Torres MD
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Multi-institutional Phase II Study to Evaluate Efficacy and Safety of TAlazoparib Radiotherapy and Atezolizumab in gBRCA 12 Negative Patients With PD-L1 Metastatic Triple Negative Breast Cancer
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study has been terminated due to Lack of Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TARA
Brief Summary:
This is a Phase II study designed to assess efficacy and safety of talazoparib high dose radiation and atezolizumab in patients with metastatic TNBC that is PD-L1 positive A total of 23 gBRCA pathogenic variant negative patients will be enrolled All patients will be treated with induction talazoparib of 1mg PO daily starting Day 1 Patients will then receive 8 Gy x 3 fractions to 2-4 metastatic lesions beginning Day 1213 or 14 and given QOD 840 mg of atezolizumab will be given intravenously IV on Day 15 of the 1st cycle and then on Day 1 and Day 15 of the remaining cycles The sequence of administration is not specified on the days in which talazoparib and atezolizumab are given on the same day Each cycle equals 28 days Treatment will continue until progression or severe toxicity
A safety lead in of up to 6 patients will be performed Immune-related and non-immune related adverse events will be tracked up to 12 weeks post initiation of atezolizumab as the majority of treatment-related toxicities from talazoparib radiation and atezolizumab occur within this time period
A safety lead in of up to 6 patients will be performed Immune-related and non-immune related adverse events will be tracked up to 12 weeks post initiation of atezolizumab as the majority of treatment-related toxicities from talazoparib radiation and atezolizumab occur within this time period
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