Breast CancerNCT03719833
Sentinel Lymph Node Biopsy After Neoadjuvant Treatment in Breast Cancer Patents
An observational study of Breast Cancer and Sentinel Lymph Node Biopsy, run by Clinical Hospital Center Rijeka at 1 site in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Sentinel Lymph Node Biopsy, Neoadjuvant Chemotherapy
- How many people
- 230 participants
- Where
- 1 siteCroatia
- Study dates
- 21 Sep 2018to 28 Jul 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Groups will be formed of the breast cancer patients who meet the eligible criteria treated in Clinical Hospital Centar Rijeka in a defined period
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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 hypersensitivity or allergy to radiocolloid
- Patients without complete documentation required for this study
- Pregnant patients
- Psychiatric patients
- Male patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
This clinical trial is designed as a prospective, observational, non-randomized clinical trial of 8-9 years of overall duration, but the first results and conclusions (secondary outcomes) could be achieved in 3-4 years from the beginning of the study.
Based on ultrasound and/or magnetic resonance assessment of primary tumour dimensions, pathological report of core needle biopsy, ultrasound evaluation of axillary lymph nodes and cytologically proven positive lymph nodes, patients would be divided into three predefined groups and would undergo predetermined group protocol.
Group 1 (T1-2 N0 M0) protocol: Surgery is primary treatment (quadrantectomy/mastectomy and sentinel lymph node biopsy).
Group 2 (T2-3 N0 M0) protocol: Neoadjuvant oncological treatment is primary therapy followed by surgery (quadrantectomy/mastectomy and sentinel lymph node biopsy) and afterwards by adjuvant oncological treatment. Before neoadjuvant treatment, all patients would undergo magnetic resonance (MR) imaging and ultrasound-guided placement titanium clip in the primary tumour site. Clinical assessment of the effectiveness of neoadjuvant treatment would be evaluated by breast MR imaging in the middle and at the end of the neoadjuvant systemic treatment.
Group 3 (T1-3 N1-2 M0) protocol includes the Group 2 protocol in addition to FNA (cytology) proof of positive node, ultrasound-guided marking positive node with titanium clip before starting neoadjuvant protocol, ultrasound and MR imaging reevaluation of axillary nodes at the end of neoadjuvant treatment and for those patients who achieve complete clinical remission of axillary lymph nodes, biopsy of marked node would be performed in context of standard surgical procedure (in addition to quadrantectomy/mastectomy and sentinel lymph node biopsy) regardless being sentinel node or not.
For the presence of any size residual tumour in lymph node(s) in groups 2 and 3 axillary lymph node dissection will be performed.
All patients would be controlled periodically in the postoperative five-year follow-up period to determine the prevalence of locoregional recurrence, progression of disease to the M1 stage and overall survival rate.
The results would be compared among groups, to available literature data and our former (historical) data of patients of the same stage but treated in the period from 2011 to 2014 (i.e. without neoadjuvant therapy).
In the first phase, which would last 3-4 years, the investigators would form three predetermined groups of breast cancer patients that would be monitored in the second phase for 5 postoperative years and analyse secondary outcome measures.
According to statistical analysis made of former data of Clinical Hospital Centar Rijeka, groups should be made of at least 30 patients in each group.
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 and that does not have a negative impact on the oncological principles and clinical outcomes.
Data would be collected individually for each patient during the diagnostic and therapeutic period and in the follow-up period (periodic ambulance controls) for 5 postoperative years.
Data would be recorded on appropriate forms. After data completion, the principal investigator would import encoded data into the register. All data would be available to all members of the investigation team, members of Ethic Committee and a person in charge of statistic analysis. Data collected in this trial would be used for publications and self-control of our multidisciplinary team for breast cancer.
- Keywords
- Breast Cancer, Sentinel Lymph Node Biopsy, Neoadjuvant Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1-control group-T1-T2 N0 M0 | Breast cancer patients in T1 N0 M0 stage at the time of diagnosis who initially undergo surgical treatment (quadrantectomy/mastectomy + sentinel lymph node biopsy). All patients will be followed for 5 years after surgery | |
| 2-T2-T3 N0 M0 | Breast cancer patients in the T2-T3 N0 M0 stage at the time of diagnosis who undergo neoadjuvant oncological treatment followed by surgery (quadrantectomy/mastectomy + sentinel lymph node biopsy). For the presence of any residual tumour in lymph node(s) at the final pathology report, ALND will be performed. All patients will be followed for 5 years after surgery | |
| 3-T1-T3 N1-N2 M0 | Breast cancer patients in T1-T3 N1-N2 M0 stage at the time of diagnosis who undergo neoadjuvant oncological treatment followed by ultrasound reevaluation of axillary lymph nodes that indicate complete clinical axillary remission. The surgical procedure that would be performed is quadrantectomy/mastectomy + sentinel lymph node biopsy. Before initiating neoadjuvant treatment biopsy (FNA) proven positive node will be marked with a titanium clip and at the time of surgery removed and pathologically examined regardless presenting as a sentinel node or not. For the presence of any residual tumour in lymph node(s) at the final pathology report, ALND will be performed All patients will be followed for 5 years after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of sentinel lymph node biopsy procedure on locoregional recurrence for group 3 sentinel node negative patients
Locoregional recurrence for group 3 sentinel node negative patients compared to group 1 and 2, to our former (hystorical) data and literature data
Measured: 5 postoperative years
Correlation of sentinel node negative patients from group 3 patients and overall survival
Overall survival from sentinel node negative patients from group 3 compared to overall survival from sentinel node positive patients from group 3 and overall survival from patients from group 3 that did not achieve complete clinical axillary remission.
Overall survival for group 3 sentinel node negative patients compared to group 1 and 2 and to our former data (patients of same stage at diagnosis treated without neoadjuvant systemic therapy)
Measured: 5 postoperative years
Correlation of sentinel node negative patients from group 3 and disease progression free survival
Disease progression free survival from sentinel node negative patients from group 3 compared to disease progression free survival from sentinel node positive patients from group 3 and disease progression free survival from patients from group 3 that did not achieve complete clinical axillary remission.
Disease progression free survival for group 3 sentinel node negative patients compared to group 1 and 2 and to our former data (patients of same stage at diagnosis treated without neoadjuvant systemic therapy)
Measured: 5 postoperative years
Secondary outcomes (2)
Evaluate the correlations of axillary response to neoadjuvant treatment and pathological characteristic of tumor
Statistical analysis of treated patients and outcomes of neoadjuvant treatment-analysis of complete pathological axillary remission related to characteristics of primary tumor (type, grade, size, proliferation index and presence of lymphovascular invasion) Evaluate when is nodal disease indication for neoadjuvant treatment regardless the tumor size
Measured: 4 years
Evaluate accuracy of standard breast MR imaging in axillary lymph node evaluation after neoadjuvant treatment (overall and related to tumor subtypes)
Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of breast MR imaging in evaluation of axillary lymph nodes after neoadjuvant treatment
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start21 Sep 2018
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Center Rijeka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Car Peterko, Clinical Hospital Center Rijeka
- Investigators
- Ana Car Peterko, Principal investigator, Clinical Hospital Centar Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719833
- Sponsor's protocol ID
- SLNB-ACP
- Status last verified
- Jul 2025
- First submitted
- 23 Oct 2018
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03719833
- Acronym / sponsor ID
- SLNB-ACP
- Keywords
- Breast Cancer, Sentinel Lymph Node Biopsy, Neoadjuvant Chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Clinical Hospital Center RijekaUniversity, hospital or other
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical trial is designed as a prospective, observational, non-randomized clinical trial of 8-9 years of overall duration, but the first results and conclusions (secondary outcomes) could be achieved in 3-4 years from the beginning of the study.
Based on ultrasound and/or magnetic resonance assessment of primary tumour dimensions, pathological report of core needle biopsy, ultrasound evaluation of axillary lymph nodes and cytologically proven positive lymph nodes, patients would be divided into three predefined groups and would undergo predetermined group protocol.
Group 1 (T1-2 N0 M0) protocol: Surgery is primary treatment (quadrantectomy/mastectomy and sentinel lymph node biopsy).
Group 2 (T2-3 N0 M0) protocol: Neoadjuvant oncological treatment is primary therapy followed by surgery (quadrantectomy/mastectomy and sentinel lymph node biopsy) and afterwards by adjuvant oncological treatment. Before neoadjuvant treatment, all patients would undergo magnetic resonance (MR) imaging and ultrasound-guided placement titanium clip in the primary tumour site. Clinical assessment of the effectiveness of neoadjuvant treatment would be evaluated by breast MR imaging in the middle and at the end of the neoadjuvant systemic treatment.
Group 3 (T1-3 N1-2 M0) protocol includes the Group 2 protocol in addition to FNA (cytology) proof of positive node, ultrasound-guided marking positive node with titanium clip before starting neoadjuvant protocol, ultrasound and MR imaging reevaluation of axillary nodes at the end of neoadjuvant treatment and for those patients who achieve complete clinical remission of axillary lymph nodes, biopsy of marked node would be performed in context of standard surgical procedure (in addition to quadrantectomy/mastectomy and sentinel lymph node biopsy) regardless being sentinel node or not.
For the presence of any size residual tumour in lymph node(s) in groups 2 and 3 axillary lymph node dissection will be performed.
All patients would be controlled periodically in the postoperative five-year follow-up period to determine the prevalence of locoregional recurrence, progression of disease to the M1 stage and overall survival rate.
The results would be compared among groups, to available literature data and our former (historical) data of patients of the same stage but treated in the period from 2011 to 2014 (i.e. without neoadjuvant therapy).
In the first phase, which would last 3-4 years, the investigators would form three predetermined groups of breast cancer patients that would be monitored in the second phase for 5 postoperative years and analyse secondary outcome measures.
According to statistical analysis made of former data of Clinical Hospital Centar Rijeka, groups should be made of at least 30 patients in each group.
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 and that does not have a negative impact on the oncological principles and clinical outcomes.
Data would be collected individually for each patient during the diagnostic and therapeutic period and in the follow-up period (periodic ambulance controls) for 5 postoperative years.
Data would be recorded on appropriate forms. After data completion, the principal investigator would import encoded data into the register. All data would be available to all members of the investigation team, members of Ethic Committee and a person in charge of statistic analysis. Data collected in this trial would be used for publications and self-control of our multidisciplinary team for breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1-control group-T1-T2 N0 M0 | – | –Breast cancer patients in T1 N0 M0 stage at the time of diagnosis who initially undergo surgical treatment (quadrantectomy/mastectomy + sentinel lymph node biopsy). All patients will be followed for 5 years after surgery |
| 2-T2-T3 N0 M0 | – | –Breast cancer patients in the T2-T3 N0 M0 stage at the time of diagnosis who undergo neoadjuvant oncological treatment followed by surgery (quadrantectomy/mastectomy + sentinel lymph node biopsy). For the presence of any residual tumour in lymph node(s) at the final pathology report, ALND will be performed. All patients will be followed for 5 years after surgery |
| 3-T1-T3 N1-N2 M0 | – | –Breast cancer patients in T1-T3 N1-N2 M0 stage at the time of diagnosis who undergo neoadjuvant oncological treatment followed by ultrasound reevaluation of axillary lymph nodes that indicate complete clinical axillary remission. The surgical procedure that would be performed is quadrantectomy/mastectomy + sentinel lymph node biopsy. Before initiating neoadjuvant treatment biopsy (FNA) proven positive node will be marked with a titanium clip and at the time of surgery removed and pathologically examined regardless presenting as a sentinel node or not. For the presence of any residual tumour in lymph node(s) at the final pathology report, ALND will be performed All patients will be followed for 5 years after surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Groups will be formed of the breast cancer patients who meet the eligible criteria treated in Clinical Hospital Centar Rijeka in a defined period
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of sentinel lymph node biopsy procedure on locoregional recurrence for group 3 sentinel node negative patients
Time frame: 5 postoperative years
Locoregional recurrence for group 3 sentinel node negative patients compared to group 1 and 2, to our former (hystorical) data and literature data
Correlation of sentinel node negative patients from group 3 patients and overall survival
Time frame: 5 postoperative years
Overall survival from sentinel node negative patients from group 3 compared to overall survival from sentinel node positive patients from group 3 and overall survival from patients from group 3 that did not achieve complete clinical axillary remission. Overall survival for group 3 sentinel node negative patients compared to group 1 and 2 and to our former data (patients of same stage at diagnosis treated without neoadjuvant systemic therapy)
Correlation of sentinel node negative patients from group 3 and disease progression free survival
Time frame: 5 postoperative years
Disease progression free survival from sentinel node negative patients from group 3 compared to disease progression free survival from sentinel node positive patients from group 3 and disease progression free survival from patients from group 3 that did not achieve complete clinical axillary remission. Disease progression free survival for group 3 sentinel node negative patients compared to group 1 and 2 and to our former data (patients of same stage at diagnosis treated without neoadjuvant systemic therapy)
2 secondary outcomes
Evaluate the correlations of axillary response to neoadjuvant treatment and pathological characteristic of tumor
Time frame: 4 years
Evaluate accuracy of standard breast MR imaging in axillary lymph node evaluation after neoadjuvant treatment (overall and related to tumor subtypes)
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Car Peterko principal investigator
Clinical Hospital Centar Rijeka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Sentinel Lymph Node Biopsy, run by Clinical Hospital Center Rijeka at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of sentinel lymph node biopsy procedure on locoregional recurrence for group 3 sentinel node negative patients (time frame: 5 postoperative years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.