Clinical trial Recruiting at 2 sites Observational Ages 18 and up Women only

Evaluating breast cancer treatment effectiveness using artificial intelligence

Official title: Prospective Validation and Application of an Artificial Intelligence-based Model for Evaluating the Efficacy of Breast Cancer Patients After Neoadjuvant Therapy

Run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT06649565 · Data updated 2026-11-12

This study is testing whether an artificial intelligence tool can help doctors better predict how well neoadjuvant therapy works for breast cancer patients using MRI images and clinical data.

Quick facts

Study typeObservational
Ages18 Years and up
SexWomen only
Enrollment300 (estimated)
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Academic / other
Locations2 sites (Beijing, Beijing Municipality and 1 other locations)
StatusRecruiting
StartedJanuary 1, 2024
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedOctober 18, 2024
Trial IDNCT06649565 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are female patients aged 18 and older with confirmed invasive breast cancer who are scheduled for neoadjuvant therapy and subsequent surgery.

Probably not a fit

Patients with bilateral breast cancer, multiple lesions, or those who have received prior anti-tumor treatments may not benefit from this study.

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

What this trial studies

This study aims to validate an artificial intelligence-based model designed to non-invasively evaluate the efficacy of neoadjuvant therapy in breast cancer patients. It involves the prospective collection of MRI images and clinical data from multiple centers, which will be processed and analyzed using AI techniques to enhance the prediction of treatment outcomes. The goal is to improve the accuracy and versatility of efficacy assessments, potentially reducing the need for surgical interventions. By integrating imaging genomics and clinical characteristics, the study seeks to establish a robust model for predicting pathological complete response in breast cancer patients.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate non-invasive evaluations of treatment efficacy, potentially sparing patients from unnecessary surgeries.

How similar studies have gone: While there have been studies exploring AI in medical imaging, this specific multi-center approach for breast cancer efficacy evaluation is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients who were treated in the above research centers between January 1, 2024 and October 31, 2025;
* ≥18 years old, female, ECOG score ≤2;
* Pathological biopsy confirmed invasive breast cancer;
* AJCC (8th edition) stage I-III;
* MRI imaging data before and after neoadjuvant therapy;
* Planned mastectomy or breast-conserving surgery after neoadjuvant therapy, and postoperative pathological information obtained.

Exclusion Criteria:

* Bilateral breast cancer, multiple lesions, or occult breast cancer;
* Poor MRI data quality;
* Patients who had received other anti-tumor treatments before enrollment;
* Patients with other malignant tumors

Where it's running

  • Sanhuan Cancer Hospital, Chaoyang District, Beijing(Cancer Hospital, Chinese Academy of Medical Sciences, close medical alliance)
    Beijing, Beijing Municipality, China
    Recruiting
  • Cancer Hospital, Chinese Academy of Medical Sciences
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.