Ataraxis AI test to predict response to neoadjuvant chemotherapy in breast cancer
A Prospective Non-Interventional Study Using a Multi-Modal Prognostic Test (Ataraxis) for Evaluating the Clinical Integration in Early-Stage Invasive Breast Cancer
This project will try the Ataraxis AI test on digitized biopsy slides and basic clinical data to see if it can predict which adults with stage I–III breast cancer will have a complete response to neoadjuvant chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Incheon St.Mary's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Incheon) |
| Trial ID | NCT07327970 on ClinicalTrials.gov |
What this trial studies
This observational, single-center study integrates the Ataraxis AI model into routine clinical workflow using digitized H&E core biopsy images plus basic clinical variables (age, tumor stage, hormone receptor status) to generate a risk score. It has two stages: Stage 1 (30 patients) examines practical workflow factors such as ease of use, report clarity, and processing time, and Stage 2 (70–120 additional patients) validates AI-predicted pathological complete response (pCR) against surgical pathology outcomes. Treating physicians remain blinded to AI predictions to avoid altering clinical decisions based on the score. Primary endpoints are workflow feasibility metrics in Stage 1 and the accuracy of pCR prediction compared with surgical outcomes in Stage 2.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed Stage I–III invasive breast cancer who are planned for neoadjuvant chemotherapy, have H&E-stained core needle biopsy slides available, and can provide informed consent.
Not a fit: Patients with metastatic (Stage IV) disease, those not eligible for neoadjuvant chemotherapy, or those without obtainable biopsy slides are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, the test could help identify who is likely to achieve a pathological complete response and support more personalized neoadjuvant treatment decisions.
How similar studies have performed: Prior retrospective development studies reported that similar AI approaches can predict recurrence or response with accuracy comparable to or better than some genomic tests, but prospective real-world validation is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Incheon
- Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea — Incheon, South Korea (Recruiting)
Study contacts
- Study coordinator: Young Joon Kang, Ph.D.
- Email: yjkang.md@gmail.com
- Phone: +82322805179
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.