A Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)

NANot yet recruitingINTERVENTIONAL
Enrollment

175

Participants

Timeline

Start Date

October 28, 2025

Primary Completion Date

August 4, 2027

Study Completion Date

August 4, 2029

Conditions
Breast CancerBreast CarcinomaCancer of the BreastMalignant Neoplasm of Breast
Interventions
DEVICE

Expression Networks for highLIGHting Tumor vulnerabilities (ENLIGHT)

This is a computational algorithm that takes RNA-seq data from tumor FFPE blocks and, given a list of pre-specified treatments, generates as output the predicted responses to those treatments.

DEVICE

TruSight(R) Oncology 500

TSO500 uses formalin-fixed, paraffin-embedded (FFPE) tumor blocks to generate a 523-gene DNA panel (with tumor mutational burden and microsatellite instability) to assess for biomarkers linked to FDA-approved, on-label therapies as well as whole-exome RNA-seq that can be used with the ENLIGHT algorithm.

DEVICE

TruSeq Matched Tumor Normal Whole Exome Sequencing Assay

The TruSeq Matched Tumor-Normal Whole Exome Sequencing assay is a next-generation sequencing assay that uses tumor DNA from formalin-fixed, paraffin-embedded (FFPE) tumor blocks and germline DNA drawn from blood to provide extended sequencing information on the tumor as well as any pathogenic variants, likely pathogenic variants, and variants of uncertain significance in 156 genes from the normal blood sample.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH