Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06856616

Predicting Long-Term Clinical Outcomes in Chinese Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

At present, the majority of studies on neoadjuvant chemotherapy (NAC) in patients with breast cancer (BC) use pathological complete response (pCR) as a surrogate marker for patient prognosis, with significant improvements in pCR indicating better long-term survival. However, there is still a lack of non-invasive tools for accurately predicting the prognosis and pCR of BC patients undergoing NAC. Recent research has introduced emerging artificial intelligence machine learning (ML) and deep learning (DL) algorithms such as Bayesian methods, K-nearest neighbors (KNN), decision trees, support vector machines (SVM), XGBoost, ResNet, convolutional neural networks, and Transformer models, which have brought new avenues of exploration for cancer researchers.

The integration of AI with imaging, pathology, genomics, and other multi-omics has non-invasively improved preoperative diagnosis of breast cancer and, when combined with clinical factors, can assess postoperative survival. Moreover, current research data is limited, and reliable predictive models require extensive data for training. Therefore, establishing a multi-center database is essential.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Ming Niu

Harbin, Longjiang Hei, 150000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with invasive breast cancer who received neoadjuvant chemotherapy (NAC) treatment in various hospitals from 2008 to 2019 (follow-up endpoint December 31, 2024)
  • Women with primary breast cancer (Stage II-III) confirmed by pre-NAC needle biopsy, along with recorded clinical, pathological, and prognostic information
  • With MR images before the first cycle of NAC and before surgery
  • With pathological HE staining images, including biopsy pathology and postoperative major pathology

Exclusion criteria

  • Any form of treatment was received before NAC, including endocrine therapy, radiotherapy, and chemotherapy
  • Disease metastasis occurred during NAC
  • Breast cancer patients with secondary malignancies from other cancers
  • Patients did not complete surgery and were lost to follow-up

Treatment and study plan

Primary outcomes

  1. 5-10 year survival rate

    Time frame: 2008-2019

    5-10 year survival rate of female breast cancer patients treated with neoadjuvant chemotherapy

Sponsors and collaborators

Lead sponsor

The Third Affiliated Hospital of Harbin Medical University

Other

Registry information

Official study title

Machine Learning Models for Predicting Long-Term Clinical Outcomes in Chinese Female Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 4, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.