Prospective Validation of Ataraxis AI Test for Predicting Treatment Response in Neoadjuvant Breast Cancer (ATARAXIS NEOP)

Young-Joon Kang

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Diagnostic Test: multi-modal foundation AI test

Study type: Observational

Funder types: Other

Identifiers

NCT07327970

ATARAXIS NEOP

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

NAC Patients with AI Assessment

Description:

Stage I-III invasive breast cancer patients undergoing neoadjuvant chemotherapy. All participants receive standard-of-care treatment. AI analysis is performed but results remain blinded from treating physicians during NAC. AI results are disclosed only after surgery and pCR assessment for retrospective evaluation. Treatment decisions are made independently of AI results.

Treatment:

Diagnostic Test: multi-modal foundation AI test