Prospective Validation of Ataraxis AI Test for Predicting Treatment Response in Neoadjuvant Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: multi-modal foundation AI test.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Non-Interventional Study Using a Multi-Modal Prognostic Test (Ataraxis) for Evaluating the Clinical Integration in Early-Stage Invasive Breast Cancer
Overview
This study evaluates the real-world clinical workflow integration of a previously developed artificial intelligence (AI) prognostic test in breast cancer patients receiving neoadjuvant chemotherapy, and validates its accuracy in predicting treatment response. The Ataraxis AI test analyzes digitized images of tumor biopsy slides combined with basic clinical information (age, tumor stage, hormone receptor status) to generate a risk score. Prior studies showed the AI test can predict cancer recurrence with accuracy comparable to or better than existing genomic tests. The study has two stages: * Stage 1 (30 patients): Assess whether the AI test can be practically integrated into routine clinical workflow, including ease of use, report clarity, and time requirements. * Stage 2 (70-120 additional patients): Validate the accuracy of AI-predicted pathological complete response (pCR) rates against actual surgical outcomes. This study uses a blinded design where treating physicians remain blinded to AI results until post-surgical pCR assessment. AI analysis is performed by the research coordinator in collaboration with Ataraxis. After pCR evaluation, AI results are disclosed and physicians complete surveys assessing hypothetical treatment changes. This design eliminates AI influence on treatment decisions and ensures independent validation. Participants are adults with Stage I-III breast cancer planned for neoadjuvant chemotherapy. The study involves no additional procedures beyond standard care except for completing surveys about the AI test experience.
Interventions
- Diagnostic test multi-modal foundation AI test
Multi-modal AI test combining digital pathology features from H\&E-stained core needle biopsy slides with clinical information (age, molecular biomarkers, TNM stage) to generate a continuous risk score (0-1) predicting pathological complete response. Results provided as reference information only; does not influence treatment decisions.
Primary outcome measures
- Stage 1 - Feasibility: Clinical Workflow Compatibility Score [Time frame: Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)]
- pCR Prediction: pCR Prediction Accuracy (AUC-ROC) [Time frame: Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)]
Secondary outcome measures (5)
- Subtype-specific pCR Prediction Accuracy [Time frame: Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)]
- Sensitivity and Specificity of pCR Prediction [Time frame: Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)]
- AI Test Processing Time [Time frame: Within 2 weeks after enrollment]
- Hypothetical Treatment Change Rate [Time frame: After AI result disclosure following surgery (approximately 5-7 months per participant)]
- Correlation Between AI Score and Established Prognostic Factors [Time frame: Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)]
Eligibility criteria
Inclusion criteria
- Histologically confirmed Stage I-III invasive breast cancer
- Planned for neoadjuvant chemotherapy
- H\&E-stained slides available from core needle biopsy
- Age 18 years or older
- Able to provide written informed consent
Exclusion criteria
- Metastatic breast cancer (Stage IV)
- Not a candidate for neoadjuvant chemotherapy
- H\&E slides not obtainable from core needle biopsy
- Unable to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea — Incheon
Identifiers
NCT: NCT07327970 · ATARAXIS NEOP