NCT05464082

Functional Precision Oncology to Predict, Prevent, and Treat Early Metastatic Recurrence of TNBC

Towards Functional Precision Oncology to Predict, Prevent, and Treat Early Metastatic Recurrence of Triple Negative Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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-low/Her2 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-low/Her2 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.

Conditions

• Breast Cancer Recurrent

Interventions

Type	Name	Description
OTHER	Functional Precision Oncology	Patient derived models (PDMs), comprising patient derived xenografts (PDXs) and organoids (PDO and PDxO),

Timeline

• Start date: 2023-01-06
• Primary completion: 2026-09-30
• Completion: 2028-09-30
• First posted: 2022-07-19
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States