Spots Global Cancer Trial Database for Functional Precision Oncology to Predict, Prevent, and Treat Early Metastatic Recurrence of TNBC

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Trial Identification

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

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

Study ID: NCT05464082

Conditions

Breast Cancer Recurrent

Interventions

Functional Precision Oncology

Study Description

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-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.