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

Peking University

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT04457700

BCP28

Details and patient eligibility

About

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

Full 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.

Enrollment: 218 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

218 participants in 1 patient group

Triple-negative and HER2 Positive breast cancer

Description:

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.