TILs have been shown to be predictive for response to neo-adjuvant chemotherapy in patients with TNBC in multiple studies (Level-1B evidence for clinical validity as per REMARK criteria). TNBC patients with excellent survival outcome and low incidence of metastasis can be identified using a manual TIL score.
Furthermore, a fully end-to-end blinded evaluation of the same algorithm to be used in this study achieved \>90% accuracy for predicting disease free survival (DFS) and overall survival (OS) in the pooled analysis of seven adjuvant phase-III TNBC trials.
Age ≥18 years
Confirmed diagnosis of triple negative breast cancer (non-metastatic)
Planned for neo-adjuvant systemic therapy
Written consent to generic Tissue for Research donation
Patients declined consent for generic Tissue for Research donation
Patients with triple negative breast cancer requiring neoadjuvant systemic therapy
Cohort
Prospective
AI-analysis on diagnostic and surgical specimens
Other interventionThe analysis will report a list of AI-based biomarkers to assess the tumour-immune spatial microenvironment as well as final spatial immune-ecology prognostic (SIPA) reports for every patient.
To determine the reliability and performance of the process and AI tool
Success rate of digitization of H\&E slides \& Turnaround time for biomarker report within standard patient pathways
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Institute of Cancer Research, United Kingdom
Lead sponsor
Case45 Ltd
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
