Ignite Creation Date:
2024-05-06 @ 5:52 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05464082
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2022-07-15
Brief Title:
Functional Precision Oncology to Predict Prevent and Treat Early Metastatic Recurrence of TNBC
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Towards Functional Precision Oncology to Predict Prevent and Treat Early Metastatic Recurrence of Triple Negative Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-02
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:
TOWARDS-II
Brief Summary:
This is a prospective phase 2 study to use Functional Precision Oncology FPO to predict prevent and treat early metastatic recurrence in subjects with HR-lowHer2 negative or triple negative breast cancer
Detailed Description:
The aim of this clinical trial is to extend the findings of the investigators first observational clinical study titled Towards personalized medicine patient derived breast tumor grafts as predictors of relapse and response to therapy TOWARDS-I In TOWARDS-II the investigators will develop patient derived models PDMs comprising patient derived xenografts PDXs and organoids PDO and PDxO from patients newly diagnosed with local or locally advanced hormone receptor-lowHer2 negative or triple negative breast cancer The investigators will prospectively evaluate the correlation between PDX engraftment with recurrence Using PDMs the investigators will perform genomic studies and functional drug screens FPO Upon disease recurrence the investigators will return the results to the physician with the intent to inform treatment selection
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