SURPASS Retrospective Study

NCT ID: NCT05779982

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2023-02-28

Brief 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

Breast Cancer; Breast MRI; Neoadjuvant Systemic Therapy; Sentinel Lymph Node

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Multicenter retrospective cohort

This study included patients diagnosed with breast cancer who received neoadjuvant systemic therapy (NAST) followed by curative surgery between January 2013 and December 2018. All patients were cN1-3 breast cancer at initial presentation confirmed by any imaging studies (either ultrasonography or MRI) or pathological examination using ultrasonography-guided needle biopsy of suspicious axillary lymph nodes. The clinical nodal stage was determined based on findings from physical examination, with imaging studies such as ultrasonography or MRI taken into account, according to the American Join Committee on Cancer guidelines (7th edition). In addition, all patients underwent sentinely lymph node biopsy (SLNB) followed by axillary lymph node dissection. SLNB was performed using a radioactive marker, blue dye, or both (dual tracers).

Sentinel lymph node biopsy followed by axillary lymph node dissection

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sung Gwe Ahn

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

3-2022-0362

Identifier Type: -

Identifier Source: org_study_id