Multicenter Prospective Observational Cohort Study of Pre-Treatment Breast DCE-MRI-Based Artificial Intelligence Model for Predicting Populations Benefiting From Neoadjuvant Chemotherapy in Locally Advanced Triple-Negative Breast Cancer
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.
• Female patients aged ≥ 18 years.
• Histologically confirmed invasive triple-negative breast cancer; patients with ER/PR 1%-10% positive and HER2-negative status are also eligible given their biological features resembling triple-negative breast cancer.
• Clinical stage T2-3N0-3M0 or T1N1-3M0 according to AJCC 8th edition, with potential indication for neoadjuvant chemotherapy.
• Availability of both MRI and pathological biopsy materials; standardized breast DCE-MRI examination and pathological biopsy completed prior to neoadjuvant chemotherapy, with image quality satisfying requirements for model analysis.
• Patients planned to receive standard neoadjuvant chemotherapy followed by surgical treatment. Patients who are undergoing standard neoadjuvant chemotherapy or have completed neoadjuvant chemotherapy awaiting surgery are also eligible.
• Post-operative pathology available to assess neoadjuvant chemotherapy response (pCR or non-pCR).
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1; adequate function of major organs to tolerate planned therapy.
• Voluntary participation and provision of written informed consent.