Clinical trial NCT03833960: SLNB After Neoadjuvant Treatment in Node Positive Patients
Official title: Impact of Sentinel Lymph Node Biopsy After Neoadjuvant Treatment on Locoregional Control of Disease in Initially Node Positive Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sentinel Lymph Node Biopsy
Locoregional Neoplasm Recurrence
Progression, Disease
Keywords: breast cancer
Sentinel Lymph Node Biopsy
Neoadjuvant Chemotherapy
locoregional recurrence
distant recurrence
Lead sponsor: Clinical Hospital Center Rijeka
Sponsor class: OTHER
First posted: 2019-02-07
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Regional recurrence
timeFrame: 3 years
measure: Distant recurrence (progression)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
measure: Postoperative complications
timeFrame: 3 years
Locations:
Study officials:
affiliation: Clinical Hospital Center Rijeka
name: Ana C Car Peterko
role: PRINCIPAL_INVESTIGATOR
References: