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

Institute of Cancer Research, United Kingdom

Status: Not yet enrolling

Conditions: Triple Negative Breast Cancer

Treatments: Other: AI-analysis on diagnostic and surgical specimens

Study type: Observational

Funder types: Other

Identifiers

NCT06396754

CCR6030

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Patients declined consent for generic Tissue for Research donation