SURPASS Retrospective Study

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast MRI Breast Neoplasms Neoadjuvant Systemic Therapy Neoplasms Neoplasms by Site Sentinel Lymph Node Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year–90 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sentinel lymph node biopsy followed by axillary lymph node dissection

Procedure

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.

Primary outcomes

False negative rate of sentinel lymph node biopsy according to radiologic response stratified by brest cancer subtype

Time frame: up to 1 month after the breast surgery

False negative rate of sentinel lymph node biopsy according to radiologic response stratified by brest cancer subtype

Secondary outcomes

False negative rate of sentinel lymph node biopsy according to clinical nodal stage

Time frame: up to 1 month after the breast surgery

False negative rate of sentinel lymph node biopsy according to clinical nodal stage
Additional axillary lymph node metastasis rate in patients with 1-2 metastatic sentinel lymph nodes

Time frame: up to 1 month after the breast surgery

Additional axillary lymph node metastasis rate in patients with 1-2 metastatic sentinel lymph nodes

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study 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

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2023
First posted: Mar 22, 2023
Registry last updated: Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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