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NCT03719833

Sentinel Lymph Node Biopsy After Neoadjuvant Treatment in Breast Cancer Patents

Completed Last updated 30 July 2025
What this trial tests

trial in Breast Cancer in 230 participants. Completed in 28 July 2025.

Timeline
21 September 2018
Primary endpoint
28 July 2025
28 July 2025

Quick facts

Lead sponsorClinical Hospital Center Rijeka
StatusCompleted
Study typeOBSERVATIONAL
Enrollment230
Start date21 September 2018
Primary completion28 July 2025
Estimated completion28 July 2025
Sites1 location across Croatia

Conditions studied

Sponsor

Clinical Hospital Center Rijeka

Who can join

Adults 18 to 80, female only, with Breast Cancer or Sentinel Lymph Node Biopsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Clinical Hospital Center Rijeka trials

Trials by the same sponsor.

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Data sources for this page

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