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

Study Overview
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Brief Summary
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This is a prospective, single-center, non-randomized, non-controlled observational study.

Detailed Description
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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.

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

Conditions
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Triple-negative Breast Cancer, HER2-positive Breast Cancer

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Triple-negative and HER2 Positive breast cancer<br>Patients with triple-negative or HER2 Positive breast cancer, axillary lymph node metastasis who underwent NAC are eligible for this study. Axillary lymph node metastasis is confirmed by fine needle aspiration (FNA) or core needle biopsy (CNB) at initial diagnosis. CT-based radiomics will be uesd in evaluating the response and predicting pCR of metastatic lymph nodes after NAC in breast cancer patients. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The features of CT-based radiomics for axillary lymph node achieved pCR after neoadjuvant chemotherapy | 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. | within 8 weeks after obtaining the post-surgery pathological results | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receiver operating characteristic (ROC) curve analysis | 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 | within 8 weeks after obtaining the post-surgery pathological results | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Neoadjuvant chemotherapy, Lymph node, Radiomic, Pathologic complete remission