Breast CancerNCT05779982
SURPASS Retrospective Study
An observational study of Breast Cancer and Breast MRI, run by Gangnam Severance Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 90 years, women only
- Conditions the study is for
- Breast Cancer, Breast MRI, Neoadjuvant Systemic Therapy
- What is being tested?
- Sentinel lymph node biopsy followed by axillary lymph node dissection
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- case with unavailable data for breast MRI and operation
About this 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
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.
Read the 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.
- Being tested
- Sentinel lymph node biopsy followed by axillary lymph node dissection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel lymph node biopsy followed by axillary lymph node dissectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Sentinel lymph node biopsy followed by axillary lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 month after the breast surgery
Secondary outcomes (2)
False negative rate of sentinel lymph node biopsy according to clinical nodal stage
False negative rate of sentinel lymph node biopsy according to clinical nodal stage
Measured: up to 1 month after the breast surgery
Additional axillary lymph node metastasis rate in patients with 1-2 metastatic sentinel lymph nodes
Additional axillary lymph node metastasis rate in patients with 1-2 metastatic sentinel lymph nodes
Measured: up to 1 month after the breast surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study startJan 2013
- Primary completionDec 2018
- Study completionFeb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Gwe Ahn, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779982
- Sponsor's protocol ID
- 3-2022-0362
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05779982
- Acronym / sponsor ID
- 3-2022-0362
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Feb 2023 (actual)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multicenter retrospective cohort | – | Procedure: Sentinel lymph node biopsy followed by axillary lymph node dissectionThis 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). |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- case with unavailable data for breast MRI and operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel 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. | Procedure or surgery | Multicenter retrospective cohort |
Primary outcome
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
2 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast MRI, run by Gangnam Severance Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.