AI-powered pre-treatment MRI to predict chemotherapy response in HR+/HER2- breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective observational study enrolling women with HR+/HER2- breast cancer who will receive standard neoadjuvant chemotherapy. Baseline DCE-MRI scans will be analyzed by AI models to classify patients as high-benefit or low-benefit. Researchers will collect clinical data, treatment regimens, and outcomes such as residual cancer burden, response rate, disease-free survival, and overall survival to compare AI-defined high-benefit patients with historical controls. The primary endpoint is the rate of residual cancer burden 0-1 in the high-benefit group versus published data; secondary analyses explore additional correlations and long-term outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Principal investigator: Chuangui Song, doctor — Fujian Cancer Hospital
• Study coordinator: Chuangui Song, doctor
• Email: songcg1971@outlook.com
• Phone: 13960709993

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.