NCT04457700

CT-based Radiomics of ALN pCR (ypN0) in Breast Cancer Undergoing NAC

Computed Tomography-based Radiomics of Axillary Lymph Node Pathological Complete Remission (ypN0) in Breast Cancer Undergoing Neoadjuvant Chemotherapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 218 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-center, non-randomized, non-controlled observational study.

Detailed description

Almost 55-62% of patients with triple-negative or human epidermal growth factor receptor 2 (HER2) positive, node-positive breast cancer achieve an axillary pathologic complete remission (pCR) after neoadjuvant chemotherapy (NAC). To avoid surgery post-NAC, it is paramount to accurately identify patients who achieve pCR in axillary lymph node (ALN). We found that patients with normal-appearing lymph nodes on computed tomography (CT) based radiomics of the axilla after chemotherapy had a lower risk of developing residual nodal disease. However, the features of CT-based radiomics for pCR ALN following NAC has not been established yet. This study aimed to assess the performance of CT-based radiomics in evaluating the response and predicting pCR of metastatic lymph nodes after NAC in breast cancer patients.

Conditions

• Triple-negative Breast Cancer
• HER2-positive Breast Cancer

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-07-30
• Completion: 2022-12-30
• First posted: 2020-07-07
• Last updated: 2022-04-18

Locations

1 site across 1 country: China