A Prospective Non-Interventional Study Using a Multi-Modal Prognostic Test (Ataraxis) for Evaluating the Clinical Integration in Early-Stage Invasive Breast Cancer
AI test to predict breast cancer treatment response in early stages
Plain English Summary
Prospective Validation of Ataraxis AI Test for Predicting Treatment Response in Neoadjuvant Breast Cancer is a Not Applicable clinical trial sponsored by Young-Joon Kang studying Breast Cancer. This study tests an artificial intelligence (AI) tool that analyzes tumor biopsy images and patient information to predict how well breast cancer will respond to chemotherapy before surgery. It is for adults with early-stage invasive breast cancer (Stage I-III) who are scheduled to receive chemotherapy before surgery. Participation involves standard medical care for breast cancer, with researchers using the AI test on existing biopsy slides and collecting clinical information. Patients do not undergo extra procedures. Alternatives include standard genomic tests that also predict cancer recurrence, but this AI test aims to be more accessible and potentially more accurate. The trial aims to enroll 150 participants.
Official Summary
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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with a confirmed diagnosis of Stage I-III invasive breast cancer. Patients must be scheduled to receive chemotherapy before surgery and have available biopsy slides. Individuals with Stage IV (metastatic) breast cancer or those not eligible for pre-surgery chemotherapy cannot participate. Patients must be able to provide informed consent. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures will tell us how well the AI test can be integrated into regular hospital procedures and how accurately it predicts whether chemotherapy will completely eliminate the canc The specific primary outcome measures are: Stage 1 - Feasibility: Clinical Workflow Compatibility Score (Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)); pCR Prediction: pCR Prediction Accuracy (AUC-ROC) (Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to improve treatment decisions for early-stage breast cancer by providing a more accurate and potentially faster way to predict response to chemotherapy, filling a g This research targets Breast Cancer, where improved treatment options are needed.
Investor Insight
This trial signals a growing investment in AI for diagnostics, with a potential market for AI-driven prognostic tools in oncology, and a high probability of integration if proven accurate and efficien
Is This Trial Right for Me?
Ask your doctor if this AI test is suitable for your specific type of breast cancer and if it could change your treatment plan. Understand that participation involves standard care; the AI test uses existing biopsy samples and data, and its results will not influence your current treatment decisions. You will be asked to complete surveys about the AI test's usability and clarity after your surgery. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 150 participants
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 Outcomes
- Stage 1 - Feasibility: Clinical Workflow Compatibility Score (Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant))
- pCR Prediction: pCR Prediction Accuracy (AUC-ROC) (Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant))
Secondary Outcomes
- Subtype-specific pCR Prediction Accuracy (Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant))
- Sensitivity and Specificity of pCR Prediction (Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant))
- AI Test Processing Time (Within 2 weeks after enrollment)
- Hypothetical Treatment Change Rate (After AI result disclosure following surgery (approximately 5-7 months per participant))
- Correlation Between AI Score and Established Prognostic Factors (Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant))
Full 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
Trial Locations
- Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, South Korea
Frequently Asked Questions
What is clinical trial NCT07327970?
NCT07327970 is a Not Applicable OBSERVATIONAL study titled "Prospective Validation of Ataraxis AI Test for Predicting Treatment Response in Neoadjuvant Breast Cancer." It is currently recruiting and is sponsored by Young-Joon Kang. The trial targets enrollment of 150 participants.
What conditions does NCT07327970 study?
This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.
What treatments are being tested in NCT07327970?
The interventions being studied include: multi-modal foundation AI test (DIAGNOSTIC_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.
What does Not Applicable mean for NCT07327970?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07327970?
This trial is currently "Recruiting." It started on 2026-01-20. The estimated completion date is 2027-12-31.
Who is sponsoring NCT07327970?
NCT07327970 is sponsored by Young-Joon Kang. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07327970?
The trial aims to enroll 150 participants. The trial is currently recruiting and accepting new participants.
How is NCT07327970 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07327970?
The primary outcome measures are: Stage 1 - Feasibility: Clinical Workflow Compatibility Score (Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)); pCR Prediction: pCR Prediction Accuracy (AUC-ROC) (Within 4 weeks after surgery following NAC completion (approximately 5-7 months per participant)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07327970 being conducted?
This trial is being conducted at 1 site, including Incheon (South Korea).
Where can I find official information about NCT07327970?
The official record for NCT07327970 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07327970. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07327970 testing in simple terms?
This study tests an artificial intelligence (AI) tool that analyzes tumor biopsy images and patient information to predict how well breast cancer will respond to chemotherapy before surgery. It is for adults with early-stage invasive breast cancer (Stage I-III) who are scheduled to receive chemotherapy before surgery.
Why is this trial significant?
This trial matters because it aims to improve treatment decisions for early-stage breast cancer by providing a more accurate and potentially faster way to predict response to chemotherapy, filling a g
What are the potential risks of participating in NCT07327970?
The main risk is that the AI test may not be accurate for everyone, potentially leading to incorrect predictions about treatment response. There are no additional physical risks as the study uses existing biopsy slides and standard medical procedures. Potential side effects are related to the standard breast cancer treatment (chemotherapy), not the AI test itself. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07327970?
Ask your doctor if this AI test is suitable for your specific type of breast cancer and if it could change your treatment plan. Understand that participation involves standard care; the AI test uses existing biopsy samples and data, and its results will not influence your current treatment decisions. You will be asked to complete surveys about the AI test's usability and clarity after your surgery. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07327970 signal from an investment perspective?
This trial signals a growing investment in AI for diagnostics, with a potential market for AI-driven prognostic tools in oncology, and a high probability of integration if proven accurate and efficien This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves standard medical care for breast cancer, with researchers using the AI test on existing biopsy slides and collecting clinical information. Patients do not undergo extra procedures. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.