NCT07880600Recruiting
Pre-Treatment Breast DCE-MRI AI Model to Predict Neoadjuvant Chemotherapy Benefit in Locally Advanced Triple-Negative Breast Cancer
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
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 8 Oct 2026
- Start date
- Oct 2026
- Primary completion date
- Aug 2027
- Lead sponsor
- Fujian Cancer Hospital
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07880600
What you commit to
- Study type: Observational
- Planned participants: 120
- From Oct 2026 to the primary completion date, Aug 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic anti-tumor therapy for breast cancer other than neoadjuvant chemotherapy.
- Concurrent active malignancy during neoadjuvant chemotherapy or surgical period.
- No definitive surgery performed or incomplete postoperative pathological reports.
- Severe comorbidities that preclude chemotherapy or surgical intervention.
Other illness
- Inflammatory breast cancer or distant metastatic disease (M1).
- History of autoimmune diseases, such as systemic lupus erythematosus, acanthosis and other related disorders.
- Documented history of neurological or psychiatric disorders, including epilepsy, dementia, etc.
- Other conditions rendering the subject inappropriate for enrollment, in the investigator's judgment.
Other
- Contraindications to MRI or unacceptable image quality for analysis.
- Missing required clinical information, MRI images, or pathological biopsy specimens for analysis.
Who the study is looking for
- Female patients aged ≥ 18 years.
- 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.
- Clinical stage T2-3N0-3M0 or T1N1-3M0 according to AJCC 8th edition, with potential indication for neoadjuvant chemotherapy.
- 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.
- 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.
- Post-operative pathology available to assess neoadjuvant chemotherapy response (pCR or non-pCR).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1; adequate function of major organs to tolerate planned therapy.
- Voluntary participation and provision of written informed consent.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Fujian Provincial Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Not yet recruiting |
| Ningde First Hospital Coordinator of this site? Confirm its status | Ningde | China | Not yet recruiting |
| The Second Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Quanzhou | China | Not yet recruiting |
| Sanming Second Hospital Coordinator of this site? Confirm its status | Sanming | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.