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
Institute of Cancer Research, United Kingdom
Lead sponsor
Case45 Ltd
Collaborator