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

• Conditions: Triple-negative Breast Cancer; HER2-positive Breast Cancer

• Registration Number: NCT04457700
• Lead Sponsor: Peking University

Brief 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.

Study Timeline

• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-07
• Study Start: 2020-11-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-18
• Primary Completion: 2022-07-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 218

Inclusion Criteria

• Triple-negative or HER2-positve invasive breast cancer with axillary lymph node metastasis by confirmed by fine needle aspiration or core needle biopsy.
• Underwent computed tomography for assessment of axillary lymph node status before and after neoadjuvant chemotherapy.
• Attend the study voluntarily, sign the informed consent.

Exclusion Criteria

• Contradiction for adjuvant chemotherapy.
• Contradiction for proceeding surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The features of CT-based radiomics for axillary lymph node achieved pCR after neoadjuvant chemotherapy	within 8 weeks after obtaining the post-surgery pathological results	Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of CT-based radiomics for axillary lymph node status after neoadjuvant chemotherapy will be assessed.

Secondary Outcome Measures

Name	Time	Method
Receiver operating characteristic (ROC) curve analysis	within 8 weeks after obtaining the post-surgery pathological results	The diagnostic performance of CT-based radiomics for the evaluation of ALN after NAC was evaluated with receiver operating characteristic (ROC) curve analysis. The diagnostic accuracy was estimated by calculating the area under the ROC curve

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China