NCT03719833Completed
Sentinel Lymph Node Biopsy After Neoadjuvant Treatment in Breast Cancer Patents
Sentinel Lymph Node Biopsy After Neoadjuvant Oncological Treatment in Luminal B, HER-2 Positive and Triple Negative Breast Cancer Patients in Stage T1-3 N0-2 M0 at the Time of Diagnose
Source: ClinicalTrials.gov · Last updated 30 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 230 (actual)
- First submitted
- 23 Oct 2018
- Start date
- 21 Sept 2018
- Primary completion date
- 28 Jul 2025
- Lead sponsor
- Clinical Hospital Center Rijeka
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT03719833
What you commit to
- Study type: Observational
- Participants enrolled: 230
- From 21 Sept 2018 to the primary completion date, 28 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients that have had previously SLNB or ALND or radiotherapy to the axillary nodes
Other illness
- Patients with bilateral disease
- Patients that have been or are treated for other malignant disease
- Patients with hypersensitivity or allergy to radiocolloid
- Psychiatric patients
Other
- Patents in T4 stage and/or N3 stage and/or M1 stage at the time of diagnosis
- Patients with inflammatory carcinoma
- Patients with ipsilateral recurrence
- Patients with histological type-lobular and immunophenotype-Luminal A
- Patients that are not eligible for oncological treatment according to protocol, either neoadjuvant or adjuvant, or oncological treatment was interrupted (aborted or completed in another institution)
- Patients without complete documentation required for this study
- Pregnant patients
- Male patients
Who the study is looking for
- Patients must be female
- Patients must be older than 18 years of age and younger than 80 years of age
- Patients must have biopsy-proven breast cancer, histological type-ductal, immunophenotype-Luminal B, HER-2 positive and triple-negative
- Patients with nodal disease (N1-N2) must have fine needle aspiration proven positive node and marked node with titanium clip before onset of neoadjuvant treatment
- Patients treated (oncological and surgical) in Clinical Hospital Centar Rijeka from September 2018 till May 2022
- Patients must be in stage cT1-3 cN0-2 cM0 at the time of diagnosis and cN0 at the time of the surgery
- Patients that are eligible for neoadjuvant oncological treatment, accepting to undergo it and complete it
- Patients who understand, accept and have signed the approved consent form
Age in the registry: 18 years to 80 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ana Car Peterko Coordinator of this site? Confirm its status | Rijeka | Croatia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.