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

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

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 218

Contacts and Locations

• Study Contact: Name: Lize Wang, MD; Phone Number: 5001 +86-10-88271119; Email: lize2010@163.com
• Study Contact Backup: Name: Yingjian He, MD; Phone Number: 8018 +86-10-88271119; Email: mimi487@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Peking University Cancer Hospital
      • Contact: Lize Wang, MD; Phone Number: 8018 +86-10-88271119; Email: lize2010@163.com
      • Principal Investigator: Lize Wang, MD
      • Sub-Investigator: Jiwei Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Triple-negative or HER2-positve invasive breast cancer with axillary lymph node metastasis: stage T1-3N1-2M0.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Triple-negative and HER2 Positive breast cancer; 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?

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

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Lize Wang, MD, Breast center at Peking University Cancer Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2020
• Primary Completion (ANTICIPATED): July 30, 2022
• Study Completion (ANTICIPATED): December 30, 2022

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (ACTUAL): July 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Breast cancer; Neoadjuvant chemotherapy; Lymph node; Pathologic complete remission; Radiomic
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: BCP28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No