SLNB After Neoadjuvant Treatment in Node Positive Patients

December 17, 2023 updated by: Ana Car Peterko, Clinical Hospital Center Rijeka

Impact of Sentinel Lymph Node Biopsy After Neoadjuvant Treatment on Locoregional Control of Disease in Initially Node Positive Breast Cancer Patients

From May 2016 till May 2018 all breast cancer patients with operable disease submitted to surgery after neoadjuvant treatment would be divided in four groups considering initially clinical axillary stage, axillary procedure that was done, axillary response to preoperative systemic treatment and pathological axillary stage.

In first postoperative year all patients will be monitored for appearance of locoregional and distant recurrence.

Study Overview

Detailed Description

From May 2017 SLNB after neoadjuvant treatment was introduced in clinical practice for breast cancer patients presenting initially with involved axilla but shifted to clinically negative followed neoadjuvant treatment. This retrospective analysis is designed for period of one year before and one year later to compare the clinical outcomes for this patients in the setting where ALND was performed to the setting where SLNB was performed.

The main hypothesis was to establish that SLNB after neoadjuvant treatment, in initially node positive breast cancer patients that achieve complete clinical remission following neoadjuvant treatment, is reliable alternative to ALND in maintenance of locoregional control of disease.

For the purpose of this trial four groups were created and the results would be compared among them. In first postoperative year patients were monitored for the appearance of locoregional and distant recurrence.

Data were collected individually for each patient and recorded in register. All data are available to all members of investigation team, members of Ethic Committee and statistician.

Data collected in this trial would be used for publication.

Study Type

Observational

Enrollment (Actual)

65

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Groups are formed from breast cancer patients with operable disease and involved axillary nodes, submitted to preoperative systemic treatment followed by surgical procedure in CHC Rijeka in period from May 2016 till May 2018

Description

Inclusion Criteria:

  • operable breast cancer submitted to neoadjuvant treatment in CHC Rijeka, followed by surgery in period from May 2016 till May 2018

Exclusion Criteria:

  • T4 stage
  • inflammatory breast cancer
  • M1 stage at the time of diagnose
  • bilateral disease
  • multicentric disease
  • unavailable complete required data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1-cN0/pN0
Patients with initially clinically negative axilla (cN0), submitted to neoadjuvant treatment, followed by surgical procedure within ALND or SLNB was done, and the final pathological report was ypN0.
2-cN+/pN0
Patients with initially clinically involved axilla (cN1-2), submitted to neoadjuvant treatment, followed by surgical procedure within ALND or SLNB was done, and the final pathological report was complete axillary remission (ypN0).
3-cN0/pN+
Patients with initially clinically negative axilla (cN0), submitted to neoadjuvant treatment, followed by surgical procedure within SLNB was done, followed by ALND because of positive pathological report of sentinel node(s).
4-cN+/pN+
Patients with initially clinically positive axilla (cN1-3) submitted to neoadjuvant treatment, followed by surgical procedure within ALND was done and the final pathological report was ypN1-3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional recurrence
Time Frame: 3 years
All patients would be monitored in postoperative period of minimally one year for the appearance of locoregional recurrence. Results will be compared among all node negative patients (group 1 and 2) submitted to SLNB vs. ALND, and among group 2 patients only (ALND vs. SLNB).
3 years
Distant recurrence (progression)
Time Frame: 3 years
All patients would be monitored in postoperative period of minimally one year for appearance of distant recurrence (disease progression). Results will be compared among patients from groups 2 and 4 and among group 2 patients only (ALND vs SLNB).
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 3 years
To compare prolonged axillary serous secretion and arm lymphedema among patients submitted to ALND and SLNB.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ana C Car Peterko, Clinical Hospital Center Rijeka

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

February 5, 2019

First Submitted That Met QC Criteria

February 6, 2019

First Posted (Actual)

February 7, 2019

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 17, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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