VISION: Triple Negative Breast Cancer Sample and Clinical Data Acquisition Study

VISION is a commercially sponsored clinical trial designed to be a retrospective, observational non-CTIMP research study which will collect archival tumour samples from participants previously treated with chemotherapy +/- immunotherapy for early Triple Negative Breast Cancer (TNBC). Current Study design: VISION currently has 2 retrospective patient cohorts: 1. Arm A: Patients treated with neoadjuvant chemotherapy who had a complete pathological response (n = 100), 2. Arm B: Patients treated with neoadjuvant chemotherapy who had a residual cancer burden (n=100). Planned study design: Include a prospective arm, Arm C to test feasibility of generating treatment predictions in real time. Study sites: UK and Australia Study timelines: 2 years UK start date: April 26th, 2024 Datasets planned for collection are: 1. Clinical data about the individual, cancer stage at diagnosis, cancer treatment, treatment response and clinical outcome, 2. Genomic data from diagnostic breast cancer samples +/- surgical samples, 3. Whole Slide Imaging data from tumour sections. Planned Next Generation Sequencing of tumours: 1. RNA sequencing 2. DNA sequencing 3. Other NGS approaches or -OMICS (subject to tissue availability) Planned tissue collection: Tissue type: Archival FFPE samples Diagnostic samples (before chemotherapy) +/- surgical samples (after chemotherapy) Planned technology development: Existing Concr technology which predicts cancer response, currently pan-cancer, in the early Triple Negative Breast Cancer population A key objective is to demonstrate that accurate prediction of therapeutic response for chemotherapy, specifically anthracyclines, taxanes, platinums, anti-metabolites with/without immunotherapy.