Sentinel Lymph Node Biopsy After Neoadjuvant Treatment in Breast Cancer Patents

NCT03719833 | Completed

• 1 other identifier: SLNB-ACP
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Breast Cancer; Sentinel Lymph Node Biopsy; Neoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (3)

• 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

  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)

  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)

  5 postoperative years

Secondary Outcomes (2)

• Evaluate the correlations of axillary response to neoadjuvant treatment and pathological characteristic of tumor

  4 years

• Evaluate accuracy of standard breast MR imaging in axillary lymph node evaluation after neoadjuvant treatment (overall and related to tumor subtypes)

  4 years

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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 hypersensitivity or allergy to radiocolloid
• Patients without complete documentation required for this study
• Pregnant patients
• Psychiatric patients
• Male patients

Sponsors & Collaborators

• Clinical Hospital Center Rijeka: lead

Study Sites (1)

Ana Car Peterko

Rijeka, Croatia, 51000, Croatia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ana Car Peterko

  Clinical Hospital Centar Rijeka

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: general surgeon, surgical oncologist, FEBS, CEBS

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 25, 2018
• Study Start: September 21, 2018
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)