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.
Study Type
OBSERVATIONAL
Enrollment
150
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.
Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Incheon, South Korea
RECRUITINGStage 1 - Feasibility: Clinical Workflow Compatibility Score
Mean score on 5-point Likert scale assessing AI system integration into existing clinical workflow, including ease of use, report comprehensibility, credibility, and time burden. Higher scores indicate better compatibility.
Time frame: Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)
pCR Prediction: pCR Prediction Accuracy (AUC-ROC)
Area under the receiver operating characteristic curve for AI-predicted pCR probability versus actual pathological complete response status (defined as ypT0/is ypN0).
Time frame: Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)
Subtype-specific pCR Prediction Accuracy
AUC-ROC for pCR prediction analyzed separately for each molecular subtype: TNBC, HER2+, and HR+/HER2-. Descriptive statistics only.
Time frame: Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)
Sensitivity and Specificity of pCR Prediction
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for AI-predicted pCR using predefined risk thresholds.
Time frame: Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)
AI Test Processing Time
Time in days from data upload to Ataraxis platform to AI result receipt.
Time frame: Within 2 weeks after enrollment
Hypothetical Treatment Change Rate
Proportion of cases where physicians indicate they would have modified treatment, assessed retrospectively after AI result disclosure following surgery and pCR evaluation. Includes regimen change, pembrolizumab addition/removal, cycle adjustment, or NAC omission.
Time frame: After AI result disclosure following surgery (approximately 5-7 months per participant)
Correlation Between AI Score and Established Prognostic Factors
Spearman correlation coefficients between AI risk score and Ki67, tumor grade, clinical T stage, and clinical N stage.
Time frame: Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.