SLNB After Neoadjuvant Treatment in Node Positive Patients

Sentinel Lymph Node Biopsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03833960
• Other study ID #: SLNBvsALND
• Status: Completed
• Start date: May 2016
• Est. completion date: June 2019

Study information

• Verified date: December 2023
• Source: Clinical Hospital Center Rijeka
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2019
• Est. primary completion date: May 2019
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease Progression
• Locoregional Neoplasm Recurrence
• Neoplasm Recurrence, Local
• Progression, Disease
• Recurrence
• Sentinel Lymph Node Biopsy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Center Rijeka

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative complications	To compare prolonged axillary serous secretion and arm lymphedema among patients submitted to ALND and SLNB.	3 years
Primary	Regional recurrence	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
Primary	Distant recurrence (progression)	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