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OpenTrials
Completed

NCT Number: NCT03833960

SLNB After Neoadjuvant Treatment in Node Positive 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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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).

Other outcomes

  1. Postoperative complications

    Time frame: 3 years

    To compare prolonged axillary serous secretion and arm lymphedema among patients submitted to ALND and SLNB.

Sponsors and collaborators

Lead sponsor

Clinical Hospital Center Rijeka

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 7, 2019
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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