SURPASS Retrospective Study

NCT05779982 | Completed

• 1 other identifier: 3-2022-0362
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  up to 1 month after the breast surgery

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

  up to 1 month after the breast surgery

Study Arms (1)

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).

Procedure: Sentinel lymph node biopsy followed by axillary lymph node dissection

Interventions

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.

Multicenter retrospective cohort

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 In addition, all patients underwent sentinely lymph node biopsy (SLNB) followed by axillary lymph node dissection.

You may qualify if:

• 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.

You may not qualify if:

• case with unavailable data for breast MRI and operation

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 22, 2023
• Study Start: January 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03