COGNITION Genomic Profiling to Guide Precision Treatment in Early High-Risk Breast Cancer Patients

What this Trial Is About

Researchers are investigating a genomic diagnostic platform called COGNITION to understand why some high-risk early breast cancer patients do not respond well to standard neoadjuvant chemotherapy. The study aims to create a comprehensive genomic profile of tumors before and after chemotherapy, helping to identify biomarkers for more precise, personalized treatments. This observational trial supports a linked phase II clinical trial, COGNITION-GUIDE, which uses these biomarker results to guide therapy choices. The study involves collecting fresh-frozen tumor tissue and blood samples from patients at multiple points before any treatment, after chemotherapy, and sometimes after surgery. These samples undergo detailed genomic and molecular analyses including whole-genome or exome sequencing and RNA sequencing. A multidisciplinary team reviews the data to identify treatment-relevant biomarkers and mutations. The findings guide recommendations for personalized treatment arms in the linked clinical trial. Additional research programs use leftover samples to study therapy resistance and cancer progression. Participants will be registered and monitored with clinical data and biomaterial collection from the start and every six months for up to ten years. The study collects extensive molecular and clinical information, including tumor profiles and immune environment characteristics. Researchers will track treatment responses and resistance using liquid biopsies and analyze genetic factors affecting drug metabolism. This long-term follow-up aims to build a detailed platform for precision oncology in early breast cancer.

COGNITION: Genomics-Guided Precision Oncology in Early High-Risk Breast Cancer