Pre-Treatment Breast DCE-MRI AI Model to Predict Neoadjuvant Chemotherapy Benefit in Locally Advanced Triple-Negative Breast Cancer

StatusRecruiting
PhaseNot specified
Started

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Record History

  1. Minor Study First Submitted
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 locally advanced triple-negative breast cancer. The study plans to enroll eligible locally advanced triple-negative 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, pathological complete response (pCR) status, objective response rate (ORR), and long-term survival endpoints including disease-free survival (DFS) and overall survival (OS). The primary objective compares the pCR rate between AI-defined high-benefit patients and published historical control data; secondary analyses compare ORR, pCR 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.
Trial Details
NCT Number NCT07880600
Lead Sponsor Fujian Cancer Hospital
Conditions
(from sponsor)
Breast Neoplasm Female, Triple -Negative Breast Cancer
Related terms Triple Negative Breast Neoplasms
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov