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Sentinel Lymph Node Biopsy After Neoadjuvant Treatment in Breast Cancer Patents

NCT03719833 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 230

Last updated 2025-07-30

No results posted yet for this study

Summary

This clinical trial is designed as an observational study of 8-9 years of overall duration, but the first results and conclusions could be achieved in 3-4 years. In the first phase, which would last 3-4 years, the investigators will form three predetermined groups of breast cancer patients that would be monitored in the second phase for 5 postoperative years.

All patients involved in this trial would undergo a defined protocol. All patients participating in this trial and all members of the investigation team would be completely introduced to the plan and aims of this trial.

Two main hypotheses of this trial are that SLNB does not have a negative impact on clinical outcomes (locoregional recurrence and overall survival) in initially node-positive patients who achieved complete clinically axillary remission after neoadjuvant systemic treatment and that lymph node status after neoadjuvant treatment is a significantly more relevant prognostic factor than nodal status at the time of diagnosis.

Therefore, the aim is to establish that sentinel lymph node biopsy, in node-positive breast cancer patients that achieve clinical remission after neoadjuvant treatment, is a reliable approach for surgical axillary management.

Data would be collected individually for each patient and recorded on appropriate forms. After data completion, the principal investigator would import encoded data into the register. Data collected in this trial would be used for publications.

Conditions

  • Breast Cancer
  • Sentinel Lymph Node Biopsy
  • Neoadjuvant Chemotherapy

Sponsors & Collaborators

  • Clinical Hospital Center Rijeka

    lead OTHER

Principal Investigators

  • Ana Car Peterko · Clinical Hospital Centar Rijeka

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-21
Primary Completion
2025-07-28
Completion
2025-07-28

Countries

  • Croatia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03719833 on ClinicalTrials.gov