Clinical Trials Logo
  1. Home
  2. Triple Negative Breast Cancer
  3. NCT06396754
  4. Details
NCT06396754 Clinical Trial

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

Triple Negative Breast Cancer Clinical Trial

— AIDOBE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06396754
Other study ID # CCR6030
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date October 31, 2025

Study information
Verified date April 2024
Source Institute of Cancer Research, United Kingdom
Contact Rei Kow
Phone 02034376805
Email rei.kow@icr.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date October 31, 2025
Est. primary completion date October 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• AI-analysis on diagnostic and surgical specimens
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.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Institute of Cancer Research, United Kingdom Case45 Ltd

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05174832 - Induction of Cisplatin/Nab-paclitaxel/Pembrolizumab Followed by Olaparib/Pembrolizumab Maintenance in mTNBC Patients Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Withdrawn NCT03634150 - Safety and Efficacy of IV Nerofe™ Followed by Doxorubicin, In Metastatic Ovarian Cancer and Triple Negative Breast Cancer Phase 1/Phase 2
Recruiting NCT03348098 - Clinical Study of Neoadjuvant Therapy With Apatinib and Paclitaxel in Local Advanced Triple-negative Breast Cancer Phase 2
Completed NCT04032080 - LY3023414 and Prexasertib in Metastatic Triple-negative Breast Cancer Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Withdrawn NCT02427581 - Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy Phase 1
Recruiting NCT03165487 - Comparison of the Breast Tumor Microenvironment
Completed NCT02225470 - Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes Phase 3
Recruiting NCT04452370 - Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer Phase 2
Terminated NCT04123704 - Sitravatinib in Metastatic Breast Cancer Phase 2
Recruiting NCT04758780 - Imaging Performance Assessment of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT in Metastatic Triple Negative Breast Cancer Patients Phase 2
Withdrawn NCT04268693 - Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer
Withdrawn NCT03982173 - Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors Phase 2
Not yet recruiting NCT02685657 - Neoadjuvant Chemotherapy Docetaxel With or Without SELUMETINIB in Patients With Triple Negative Breast Cancer Phase 2
Terminated NCT01918306 - GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer Phase 1/Phase 2
Completed NCT01276899 - Study to Identify Molecular Mechanisms of Clinical Resistance to Chemotherapy in Triple Negative Breast Cancer Patients
Completed NCT00998036 - Study of Temsirolimus, Erlotinib and Cisplatin in Solid Tumors Phase 1
Recruiting NCT05309655 - Cardiac Outcomes With Near-Complete Estrogen Deprivation Early Phase 1
Active, not recruiting NCT03267316 - A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors Phase 1/Phase 2