RecruitingNCT07702708

Pre-Treatment DCE-MRI AI Models Predict Neoadjuvant Chemotherapy Response in HR+/HER2- Breast Cancer

A Multicenter Prospective Observational Cohort Study: Predicting Neoadjuvant Chemotherapy Response Using Pre-Treatment DCE-MRI-Based AI Models in HR+/HER2- Breast Cancer


Sponsor

Fujian Cancer Hospital

Enrollment

100 participants

Start Date

Jun 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

This study is a multicenter, prospective, observational cohort study to evaluate the predictive performance of pre-treatment DCE-MRI-based artificial intelligence (AI) models for neoadjuvant chemotherapy benefit in HR+/HER2- breast cancer. The study plans to enroll eligible HR+/HER2- breast cancer patients receiving routine standard neoadjuvant chemotherapy and stratify participants into high-benefit and low-benefit subgroups via the established AI model based on baseline breast DCE-MRI images. All enrolled patients will undergo systematic collection of baseline clinical-pathological data, pre-treatment DCE-MRI scans, neoadjuvant chemotherapy regimens, postoperative residual cancer burden (RCB) classification, objective response rate (ORR), and long-term survival endpoints including disease-free survival (DFS) and overall survival (OS). The primary objective compares the rate of RCB 0-1 between AI-defined high-benefit patients and published historical control data; secondary analyses compare ORR, RCB 0-1 proportion, DFS and OS between AI-stratified high-benefit and low-benefit subgroups to comprehensively verify the clinical value of this imaging AI model for individualized neoadjuvant chemotherapy selection.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Pre-treatment DCE-MRI-based AI model for people with breast neoplasms and hr+/her2- breast cancer. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTPre-treatment DCE-MRI-based AI model

Preoperative dynamic contrast-enhanced MRI images are input into an artificial intelligence prediction model to stratify HR+/HER2- breast cancer patients into high and low neoadjuvant chemotherapy benefit subgroups.


Locations(5)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Fujian Provincial Hospital

Fuzhou, Fujian, China

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

Ningde First Hospital

Ningde, Ningde, China

Sanming Second Hospital

Sanming, Sanming, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07702708


Related Trials