NCT06396754

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
12mo left

Started Aug 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
2.2 years until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

April 30, 2024

Last Update Submit

March 23, 2026

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Interventions

AI-analysis on diagnostic and surgical specimensOTHER

The 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with triple negative breast cancer requiring neoadjuvant systemic therapy

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Navita Somaiah

    Institute of Cancer Research, United Kingdom

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rei Kow

CONTACT

02034376805rei.kow@icr.ac.uk

Lone Gothard

CONTACT

02086613460lone.gothard@icr.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2024

First Posted

May 2, 2024

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03