Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441890
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-05-29
Brief Title:
BRE-10 Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
BRE-10 BIomarker OptimizatioN of NeOadjuVAnt Therapy in BrEast Cancer The INNOVATE Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
BRE-10
Brief Summary:
Adult men and women with early-stage IHCFISH-defined HER2-positive breast cancer will have a MammaPrintBluePrint assay performed on the diagnostic biopsy specimen ordered by the treating Oncologist as standard care
Detailed Description:
Adult men and women with early-stage IHCFISH-defined HER2-positive breast cancer will have a MammaPrintBluePrint assay performed on the diagnostic biopsy specimen ordered by the treating Oncologist as standard care Patients whose tumors have a HER2-enriched molecular subtype on the MammaPrintBluePrint assay and are recommended for neoadjuvant chemotherapy by their treating Oncologist will be recruited for study enrollment
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?:
False
Is an FDA AA801 Violation?:
None