SLNB After Neoadjuvant Treatment in Node Positive Patients

NCT03833960 | Completed

• 1 other identifier: SLNBvsALND
• Study Type: observational
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Other Outcomes (1)

• Postoperative complications

  3 years

Study Arms (4)

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.

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).

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).

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• operable breast cancer submitted to neoadjuvant treatment in CHC Rijeka, followed by surgery in period from May 2016 till May 2018

You may not qualify if:

• T4 stage
• inflammatory breast cancer
• M1 stage at the time of diagnose
• bilateral disease
• multicentric disease
• unavailable complete required data

Sponsors & Collaborators

• Clinical Hospital Center Rijeka: lead

MeSH Terms

Conditions

Neoplasm Recurrence, Local; Disease Progression; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ana C Car Peterko

  Clinical Hospital Center Rijeka

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: general surgeon

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 7, 2019
• Study Start: May 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: December 19, 2023

Record last verified: 2023-12