Sentinel Lymph Node Biopsy After Neoadjuvant Treatment in Breast Cancer Patents (NCT03719833) | Clinical Trial Compass
CompletedNot Applicable
Sentinel Lymph Node Biopsy After Neoadjuvant Treatment in Breast Cancer Patents
Croatia230 participantsStarted 2018-09-21
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Patents in T4 stage and/or N3 stage and/or M1 stage at the time of diagnosis
* Patients with inflammatory carcinoma
* Patients with bilateral disease
* 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 that have had previously SLNB or ALND or radiotherapy to the axillary nodes
* Patients that have been or are treated for other malignant disease
* Patients with hypersensi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Impact of sentinel lymph node biopsy procedure on locoregional recurrence for group 3 sentinel node negative patients
Timeframe: 5 postoperative years
2
Correlation of sentinel node negative patients from group 3 patients and overall survival
Timeframe: 5 postoperative years
3
Correlation of sentinel node negative patients from group 3 and disease progression free survival