OncoMatch/Clinical Trials/NCT07880600
Pre-Treatment Breast DCE-MRI AI Model to Predict Neoadjuvant Chemotherapy Benefit in Locally Advanced Triple-Negative Breast Cancer
Official title: 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
Is NCT07880600 recruiting? Yes, currently enrolling (Oct 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 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: ESR1 expression (1%-10% positive)
patients with ER/PR 1%-10% positive and HER2-negative status are also eligible
Required: PR (PGR) expression (1%-10% positive)
patients with ER/PR 1%-10% positive and HER2-negative status are also eligible
Required: HER2 (ERBB2) wild-type (negative)
patients with ER/PR 1%-10% positive and HER2-negative status are also eligible
Disease stage
Required: Stage T2-3N0-3M0, T1N1-3M0 (other)
Clinical stage T2-3N0-3M0 or T1N1-3M0 according to AJCC 8th edition
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: systemic anti-tumor therapy for breast cancer other than neoadjuvant chemotherapy
Prior systemic anti-tumor therapy for breast cancer other than neoadjuvant chemotherapy
Lab requirements
Blood counts
adequate function of major organs to tolerate planned therapy
Kidney function
adequate function of major organs to tolerate planned therapy
Liver function
adequate function of major organs to tolerate planned therapy
adequate function of major organs to tolerate planned therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07880600 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anti-tumor therapy for breast cancer other than neoadjuvant chemotherapy disqualifies patients from enrollment.
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 T2-3N0-3M0 or T1N1-3M0 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