Pre-Treatment DCE-MRI AI Models Predict Neoadjuvant Chemotherapy Response in HR+/HER2- Breast Cancer
Recruiting · NCT07702708 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fujian Cancer Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Female patients aged ≥ 18 years old.
- Histopathologically confirmed invasive breast carcinoma.
- Hormone receptor positive (ER and/or PR ≥1%), HER2-negative status (IHC 0-1+, or IHC 2+ with negative FISH result).
- Clinical stage II-III breast cancer per the 8th AJCC staging system, with clinical indication for neoadjuvant chemotherapy or primary surgery.
- Standard pre-treatment breast DCE-MRI performed before neoadjuvant chemotherapy, with image quality eligible for AI model analysis.
- ECOG performance status 0 or 1; adequate function of major vital organs to tolerate planned clinical treatment.
- Voluntary participation with written informed consent obtained.
Exclusion criteria
- Prior systemic anti-tumor therapy for breast cancer other than planned neoadjuvant chemotherapy.
- Inflammatory breast cancer or distant metastatic disease (M1).
- Concurrent active malignant tumors of other origins.
- Contraindications to MRI examination or unqualified MRI images that cannot support model analysis.
- Severe comorbidities incompatible with neoadjuvant chemotherapy or surgical resection.
- Any other conditions judged ineligible for enrollment by the investigator.
Where it is running
5 locations listed.
- 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