Ignite Creation Date:
2024-05-06 @ 10:13 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03193853
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2017-06-09
Brief Title:
TAK-228 and TAK-117 Followed by Cisplatin and Nab Paclitaxel for Metastatic Triple Negative Breast Cancer
Sponsor:
Joyce OShaughnessy
Organization:
Baylor Research Institute
Study Overview
Official Title:
Phase II Clinical Trial of Treatment With TAK-228 and TAK-117 to Inhibit Homologous Recombination HR Followed by Cisplatin and Nab Paclitaxel in Patients With Chemotherapy-pretreated Metastatic Triple Negative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2023-08
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 study evaluates efficacy of TAK- 228 and TAK- 117 followed by cisplatin and nab paclitaxel in patients with metastatic triple negative breast cancer
Detailed Description:
Seventy to eighty percent of breast cancers have a gene expression profile which is characterized by homologous recombination deficiency HRD and high proliferation HRD leads to errors in DNA pathway non -homologous end joining NHEJ that repair DNA-breaks a process required for metastatic triple negative breast cancer TNBC survival The hypothesis of this pilot trial is that administration of the oral combination of TAK-228 and TAK-117 PIKTOR will inhibit NHEJ in metastatic TNBC leading at the time of disease progression to metastases that are HR-deficient and sensitive to cisplatin plus nab paclitaxel therapy
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 |
|---|---|---|---|
| Baylor 017-113 | OTHER | Baylor Scott White Research Institute | None |