Clinical Trials Directory

Trials / Completed

CompletedNCT05779982

SURPASS Retrospective Study

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

Status
Completed
Phase
Study type
Observational
Enrollment
500 (actual)
Sponsor
Gangnam Severance Hospital · Academic / Other
Sex
Female
Age
19 Years – 90 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDURESentinel lymph node biopsy followed by axillary lymph node dissectionThis 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.

Timeline

Start date
2013-01-01
Primary completion
2018-12-01
Completion
2023-02-01
First posted
2023-03-22
Last updated
2023-03-22

Source: ClinicalTrials.gov record NCT05779982. Inclusion in this directory is not an endorsement.