Deployment and Clinical Evaluation of an AI-powered Digital Oncology Biomarker Tool to guidE Treatment in TNBC

Starting soon

Conditions studied: Triple Negative Breast Cancer

In brief

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.

Key facts

Study ID

NCT06396754

Run by

Institute of Cancer Research, United Kingdom

People needed

50

Starts

2026-08-01

Expected to finish

2027-07-31

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients declined consent for generic Tissue for Research donation

Full record on ClinicalTrials.gov

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