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

HER2-positive Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04457700
• Other study ID #: BCP28
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: April 2022
• Source: Peking University
• Contact: Lize Wang, MD
• Phone: +86-10-88271119
• Email: lize2010[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: December 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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