Clinical trial NCT05779982: SURPASS Retrospective Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Breast MRI
Neoadjuvant Systemic Therapy
Sentinel Lymph Node
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 500
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: False negative rate of sentinel lymph node biopsy according to radiologic response stratified by brest cancer subtype
timeFrame: up to 1 month after the breast surgery
Secondary outcomes:
measure: False negative rate of sentinel lymph node biopsy according to clinical nodal stage
timeFrame: up to 1 month after the breast surgery
measure: Additional axillary lymph node metastasis rate in patients with 1-2 metastatic sentinel lymph nodes
timeFrame: up to 1 month after the breast surgery
Other outcomes:
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