NCT06649565 Prospective Validation and Application of an Artificial Intelligence-based Model for Evaluating the Efficacy of Breast Cancer Patients After Neoadjuvant Therapy
| NCT ID | NCT06649565 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Breast cancer has become the world's number one cancer. While its therapeutic efficacy is increasing, how to achieve non-invasive evaluation of the efficacy of neoadjuvant therapy (NAT) for breast cancer patients and thus avoid surgery has become a bottleneck problem that needs to be broken through in clinical diagnosis and treatment. Existing non-invasive evaluation strategies are limited to single-center, single-modality modeling, and have problems such as low performance and poor versatility. Therefore, in the early stage of this study, multi-modality breast cancer patient data from multiple centers across the country were collected and the establishment of an artificial intelligence (AI) efficacy prediction model was preliminarily completed. On this basis, this project intends to further improve the multi-center prospective validation study of the prediction model. The research results will help solve the scientific problem of non-invasive judgment of NAT efficacy in breast cancer patients and provide a new paradigm for the research of high-performance AI diagnosis and treatment auxiliary systems applicable to multiple centers.
Eligibility 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
Contact & Investigator
peng yuan, doctor
STUDY DIRECTOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT06649565 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06649565 currently recruiting?
Yes, NCT06649565 is actively recruiting participants. Contact the research team at yuanpengyp01@163.com for enrollment information.
Where is the NCT06649565 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT06649565 clinical trial?
NCT06649565 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The principal investigator is peng yuan, doctor at Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 300 participants.
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