OncoMatch/Clinical Trials/NCT07702708
Pre-Treatment DCE-MRI AI Models Predict Neoadjuvant Chemotherapy Response in HR+/HER2- Breast Cancer
Is NCT07702708 recruiting? Yes, currently enrolling (Sep 2026).
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (positive (≥1%))
Hormone receptor positive (ER and/or PR ≥1%)
Required: PR (PGR) expression (positive (≥1%))
Hormone receptor positive (ER and/or PR ≥1%)
Required: HER2 (ERBB2) wild-type (IHC 0-1+, or IHC 2+ with negative FISH result)
HER2-negative status (IHC 0-1+, or IHC 2+ with negative FISH result)
Disease stage
Required: Stage II, III (other)
Clinical stage II-III breast cancer per the 8th AJCC staging system, with clinical indication for neoadjuvant chemotherapy or primary surgery
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG performance status 0 or 1
Demographics
Prior therapy
Lab requirements
Blood counts
adequate function of major vital organs to tolerate planned clinical treatment
Kidney function
adequate function of major vital organs to tolerate planned clinical treatment
Liver function
adequate function of major vital organs to tolerate planned clinical treatment
adequate function of major vital organs to tolerate planned clinical treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07702708 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify