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

NCT07702708 | Recruiting

• 1 other identifier: K2026-219-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

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.

Conditions

HR+/HER2- Breast Cancer; Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Incidence of Residual Cancer Burden (RCB) 0-1

  Compare the incidence of RCB 0-1 among HR+/HER2- breast cancer patients stratified as high chemotherapy benefit by pre-treatment DCE-MRI AI model against published historical control data to verify the predictive value of the imaging AI model.

  After completion of neoadjuvant chemotherapy and definitive surgery (approximately 3-6 months after enrollment)

Secondary Outcomes (5)

• Objective response rate (ORR) of AI-defined high neoadjuvant chemotherapy benefit group

  Imaging assessment after completion of neoadjuvant chemotherapy and prior to surgery

• Between-subgroup differences in RCB 0-1 rate

  RCB classification obtained after definitive surgical resection, approximately 3-6 months after enrollment

• Between-subgroup differences in objective response rate (ORR)

  ORR imaging assessment after neoadjuvant chemotherapy before surgery

• Disease-free survival (DFS) between high and low chemotherapy benefit subgroups

  From the date of surgery until the first recurrence, metastasis, or death, whichever came first, assessed up to 60 months

• Overall survival (OS) between high and low chemotherapy benefit subgroups

  From the date of surgery until death from any cause, assessed up to 60 months

Study Arms (1)

HR+/HER2- Breast Cancer Cohort Receiving Neoadjuvant Chemotherapy

Multicenter prospective observational cohort of patients with HR+/HER2- invasive breast cancer who receive routine standard neoadjuvant chemotherapy. All participants undergo pre-treatment DCE-MRI scanning, and an MRI-based AI model is applied to stratify patients into high and low chemotherapy benefit subgroups.

Diagnostic Test: Pre-treatment DCE-MRI-based AI model

Interventions

Pre-treatment DCE-MRI-based AI model DIAGNOSTIC_TEST

Preoperative dynamic contrast-enhanced MRI images are input into an artificial intelligence prediction model to stratify HR+/HER2- breast cancer patients into high and low neoadjuvant chemotherapy benefit subgroups.

HR+/HER2- Breast Cancer Cohort Receiving Neoadjuvant Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study population consists of female patients aged 18 years or older with histologically confirmed stage II-III HR+/HER2-negative invasive breast cancer according to the 8th AJCC staging system. All participants receive routine standard neoadjuvant chemotherapy in multi-center breast cancer departments, complete standardized pre-treatment DCE-MRI with qualified imaging data, have ECOG performance status 0-1 and intact vital organ function. Subjects must satisfy all inclusion criteria, without meeting any exclusion criteria, and sign written informed consent voluntarily. Approximately 100 eligible patients will be consecutively enrolled from participating hospitals.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (5)

Fujian Cancer Hospital

Fuzhou, Fujian, China

RECRUITING

Fujian Provincial Hospital

Fuzhou, Fujian, China

RECRUITING

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

RECRUITING

Ningde First Hospital

Ningde, Ningde, China

RECRUITING

Sanming Second Hospital

Sanming, Sanming, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-fixed paraffin-embedded (FFPE) core needle biopsy and postoperative surgical pathological specimens, as well as peripheral blood samples collected before the initial cycle of neoadjuvant chemotherapy.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chuangui Song, doctor

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuangui Song, doctor

CONTACT

13960709993; songcg1971@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 14, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)