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

NCT06649565 | Recruiting

• 1 other identifier: 2024-1- 4021
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Breast MRI radiomics characteristics of breast cancer patients during neoadjuvant therapy

  Breast cancer MRI images before neoadjuvant therapy and immediately after completing neoadjuvant therapy

Study Arms (2)

Breast cancer patients who achieved pathological complete response after neoadjuvant therapy

All enrolled breast cancer patients received normal neoadjuvant therapy and subsequent surgery without intervention in the diagnosis and treatment process. They were judged to have achieved pathological complete respone based on surgical pathology.

Other: no intervention

Breast cancer patients who did not achieve pathological complete response after neoadjuvant therapy

All enrolled breast cancer patients received normal neoadjuvant therapy and subsequent surgery without intervention in the diagnosis and treatment process. They were judged as not achieving pathological complete respone based on surgical pathology.

Other: no intervention

Interventions

no intervention OTHER

no intervention

Breast cancer patients who achieved pathological complete response after neoadjuvant therapy; Breast cancer patients who did not achieve pathological complete response after neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study adopts sequential enrollment (continuously recruiting patients until the sample size requirement is met). The subjects are patients with neoadjuvant treatment for breast cancer who were treated in Beijing Second Hospital, Beijing Luhe Hospital Affiliated to Capital Medical University, and Beijing Sanhuan Cancer Hospital from January 2024 to December 2026. Each independent medical center will include 100 patients, for a total of 300 patients.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (2)

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

Beijing, Beijing Municipality, 100000, China

RECRUITING

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• peng yuan, doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

peng yuan, doctor

CONTACT

01087787242; yuanpengyp01@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: October 18, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)