Pre-Treatment Breast DCE-MRI AI Model to Predict Benefit from Neoadjuvant Chemo in Locally Advanced Triple-Negative 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 cohort study enrolling women with locally advanced triple-negative breast cancer who are planned for standard neoadjuvant chemotherapy. Baseline breast DCE-MRI scans will be analyzed with an AI model to classify patients as high-benefit or low-benefit from neoadjuvant therapy. Researchers will collect clinical-pathological data, treatment regimens, and responses (pCR, ORR) along with long-term outcomes such as DFS and OS. The primary aim is to compare pCR rates between AI-defined high-benefit patients and published historical controls. The study will help determine if MRI-based AI can guide treatment decisions in this patient group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female patients aged ≥ 18 years.
2. Histologically confirmed invasive triple-negative breast cancer; patients with ER/PR 1%-10% positive and HER2-negative status are also eligible given their biological features resembling triple-negative breast cancer.
3. Clinical stage T2-3N0-3M0 or T1N1-3M0 according to AJCC 8th edition, with potential indication for neoadjuvant chemotherapy.
4. Availability of both MRI and pathological biopsy materials; standardized breast DCE-MRI examination and pathological biopsy completed prior to neoadjuvant chemotherapy, with image quality satisfying requirements for model analysis.
5. Patients planned to receive standard neoadjuvant chemotherapy followed by surgical treatment. Patients who are undergoing standard neoadjuvant chemotherapy or have completed neoadjuvant chemotherapy awaiting surgery are also eligible.
6. Post-operative pathology available to assess neoadjuvant chemotherapy response (pCR or non-pCR).
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; adequate function of major organs to tolerate planned therapy.
8. Voluntary participation and provision of written informed consent.

Exclusion Criteria:

1. Prior systemic anti-tumor therapy for breast cancer other than neoadjuvant chemotherapy.
2. Inflammatory breast cancer or distant metastatic disease (M1).
3. Concurrent active malignancy during neoadjuvant chemotherapy or surgical period.
4. History of autoimmune diseases, such as systemic lupus erythematosus, acanthosis and other related disorders.
5. Documented history of neurological or psychiatric disorders, including epilepsy, dementia, etc.
6. Contraindications to MRI or unacceptable image quality for analysis.
7. No definitive surgery performed or incomplete postoperative pathological reports.
8. Severe comorbidities that preclude chemotherapy or surgical intervention.
9. Missing required clinical information, MRI images, or pathological biopsy specimens for analysis.
10. Other conditions rendering the subject inappropriate for enrollment, in the investigator's judgment.

Where it's running

• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Fujian Provincial Hospital
  Fuzhou, Fujian, China Not yet recruiting
• Ningde First Hospital
  Ningde, Fujian, China Not yet recruiting
• The Second Affiliated Hospital of Fujian Medical University
  Quanzhou, Fujian, China Not yet recruiting
• Sanming Second Hospital
  Sanming, Fujian, China Not yet 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.