SLNB After Neoadjuvant Treatment in Node Positive Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03833960

Enrollment

Registered

2019-02-07

Start date

2016-05-31

Completion date

2019-06-30

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

breast cancer, Sentinel Lymph Node Biopsy, Neoadjuvant Chemotherapy, locoregional recurrence, distant recurrence

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Regional recurrence	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).
Distant recurrence (progression)	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

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

Outcome results