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

ClinicalTrials.gov ID

NCT07702708

Lead Sponsor

Fujian Cancer HospitalOTHER_GOV

Overall Status

Recruiting

Study Type

Observational

Enrollment

100Estimated

Last Update Posted

Jul 14, 2026Actual

Start Date

Jun 1, 2026Actual

Primary Completion Date

Apr 30, 2027Estimated

Completion Date

Jun 30, 2027Estimated

Official Title

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

Brief 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.

• HR+/HER2- Breast Cancer
• Breast Neoplasms

• Pre-treatment DCE-MRI-based AI model

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Female patients aged ≥ 18 years old.
2. Histopathologically confirmed invasive breast carcinoma.
3. Hormone receptor positive (ER and/or PR ≥1%), HER2-negative status (IHC 0-1+, or IHC 2+ with negative FISH result).
4. Clinical stage II-III breast cancer per the 8th AJCC staging system, with clinical indication for neoadjuvant chemotherapy or primary surgery.
5. Standard pre-treatment breast DCE-MRI performed before neoadjuvant chemotherapy, with image quality eligible for AI model analysis.
6. ECOG performance status 0 or 1; adequate function of major vital organs to tolerate planned clinical treatment.
7. Voluntary participation with written informed consent obtained.

Exclusion Criteria:

1. Prior systemic anti-tumor therapy for breast cancer other than planned neoadjuvant chemotherapy.
2. Inflammatory breast cancer or distant metastatic disease (M1).
3. Concurrent active malignant tumors of other origins.
4. Contraindications to MRI examination or unqualified MRI images that cannot support model analysis.
5. Severe comorbidities incompatible with neoadjuvant chemotherapy or surgical resection.
6. Any other conditions judged ineligible for enrollment by the investigator.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Fujian Cancer HospitalOTHER_GOV

Rjwang2025@126.com13799367490

zirongjiang@outlook.com15892129077

25985991@qq.com15159110696

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