MedDataX Logo

SLNB After Neoadjuvant Treatment in Node Positive Patients

NCT ID: NCT03833960

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sentinel Lymph Node Biopsy Locoregional Neoplasm Recurrence Progression, Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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).

No interventions assigned to this group

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).

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Clinical Hospital Center Rijeka

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ana Car Peterko

general surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ana C Car Peterko

Role: PRINCIPAL_INVESTIGATOR

Clinical Hospital Center Rijeka

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SLNBvsALND

Identifier Type: -

Identifier Source: org_study_id