SURPASS Retrospective Study

Breast Cancer Clinical Trial

Official title:

Outcomes of Sentinel Node Biopsy According to MRI Response in an Association With the Subtypes in cN1-3 Breast Cancer After Neoadjuvant Systemic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05779982
• Other study ID #: 3-2022-0362
• Status: Completed
• Start date: January 2013
• Est. completion date: February 2023

Study information

• Verified date: March 2023
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aimed to determine whether sentinel lymph node biopsy (SLNB) could be a reliable option for evaluating nodal status in patients who had responded well to neoadjuvant systemic therapy (NAST), even if they had initially presented with a high nodal burden. The study investigated the outcomes of SLNB followed by axillary lymph node dissection (ALND) in this patient population, taking into account the response to NAST and the breast cancer subtype.

Description:

To determine the feasibility of sentinel lymph node biopsy (SLNB) in this study, the investigators evaluated the false-negative rate (FNR) of SLNB. The FNR was calculated as the number of patients with negative SLNs who had a residual disease in the rest of the axillary lymph nodes (ALNs) divided by the total number of patients with residual disease in either the SLNs, the rest of the ALNs, or both: FN/true-positive + FN. The investigators compared the FNR of the SLNB according to the radiologic response measured using breast MRI in each subtype. The investigators further evaluated the FNR in subgroups stratified by clinical nodal stage. Additionally, the investigators assessed additional metastatic ALNs in cases with 1-2 metastatic SLNs through the completion of ALN dissection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 2023
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 90 Years

Eligibility

Inclusion Criteria:

• cN1-3 breast cancer at initial presentation
• received neoadjuvant systemic therapy (NAST)
• received sentinel lymph node biopsy (SLNB) followed by additional axillary lymph node dissection (ALND)
• breast MRI performed at baseline and post-NAST.

Exclusion Criteria:

• case with unavailable data for breast MRI and operation

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Sentinel Lymph Node

Intervention

Procedure:
• Sentinel lymph node biopsy followed by axillary lymph node dissection
This is a retrospective study to determine the feasibility of sentinel lymph node biopsy (SLNB) after neoadjuvant systemic therapy (NAST) according to response to NAST and breast cancer subtypes. All patients received SLNB followed by axillary lymph node dissection after NAST.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	False negative rate of sentinel lymph node biopsy according to radiologic response stratified by brest cancer subtype	False negative rate of sentinel lymph node biopsy according to radiologic response stratified by brest cancer subtype	up to 1 month after the breast surgery
Secondary	False negative rate of sentinel lymph node biopsy according to clinical nodal stage	False negative rate of sentinel lymph node biopsy according to clinical nodal stage	up to 1 month after the breast surgery
Secondary	Additional axillary lymph node metastasis rate in patients with 1-2 metastatic sentinel lymph nodes	Additional axillary lymph node metastasis rate in patients with 1-2 metastatic sentinel lymph nodes	up to 1 month after the breast surgery