Ataraxis AI test to predict response to neoadjuvant chemotherapy in breast cancer
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
Run by Incheon St.Mary's Hospital · NCT07327970 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 150 (estimated) |
| Sponsor | Incheon St.Mary's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Incheon) |
| Status | Recruiting |
| Started | January 20, 2026 |
| Main results expected | August 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT07327970 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.