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Clinical validation of artificial intelligence model based on DCE-MRI for predicting the efficacy of neoadjuvant chemotherapy combined with immunotherapy in locally advanced triple negative breast cancer: a multicenter, observational, prospective study

Clinical validation of artificial intelligence model based on DCE-MRI for predicting the efficacy of neoadjuvant chemotherapy combined with immunotherapy in locally advanced triple negative breast cancer: a multicenter, observational, prospective study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600122646
Enrollment
Unknown
Registered
2026-04-16
Start date
2026-04-16
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Observation group:None

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent form for participation in the clinical study. 2. Patients with histologically confirmed triple-negative breast invasive carcinoma (patients with ER/PR 1%-10% positivity and HER2 negativity can also be included due to biological characteristics similar to triple-negative breast cancer); 3. Clinical staging: T2-3N0-3M0; T1N1-3M0; 4. Female patients aged 18 to 70; 5. No history of previous malignant tumors; 6. Eligible patients plan to receive standard neoadjuvant chemotherapy combined with immunotherapy followed by surgery; patients who are ready to receive or have completed standard neoadjuvant chemotherapy combined with immunotherapy awaiting surgery are also considered eligible. 7. Pathological neoadjuvant chemotherapy combined immunotherapy response (pCR or non-pCR) needs to be confirmed. 8. MRI and core needle biopsy are both acceptable; perform MRI and biopsy within 2 weeks before neoadjuvant chemotherapy combined with immunotherapy. 9. Perform MRI after two cycles of neoadjuvant chemotherapy combined with immunotherapy. 10. No other tumors occur during neoadjuvant chemotherapy combined with immunotherapy and surgery.

Exclusion criteria

Exclusion criteria: 1. History of previous chemotherapy, endocrine therapy, anti-HER2 biological therapy, immunotherapy, or radiotherapy; 2. History of previous malignant tumors; 3. History of autoimmune diseases, including systemic lupus erythematosus, scleroderma, etc.; 4. History of definite neurological or psychiatric disorders, including epilepsy or dementia; 5. Patients who received non-standard treatment or did not complete the neoadjuvant chemotherapy combined with immunotherapy regimen; 6. No surgery performed or incomplete postoperative pathological results; 7. Lack of clinical information, MRI images, or biopsy pathology results required for analysis; 8. Poor quality of MRI images; 9. Other reasons deemed unsuitable for inclusion by the researchers.

Design outcomes

Primary

MeasureTime frame
accuracy;Specificity;Area under the curve;

Countries

China

Contacts

Public ContactJun Tang

Sun Yat-sen University Cancer Center

tangjun@sysucc.org.cn+86 137 2488 7991

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026