Sentinel Lymph Node Biopsy After Neoadjuvant Treatment in Breast Cancer Patents
Study Details
Study Description
Brief Summary
This clinical trial is designed as observational study of overall duration of 8-9 years, but the first results and conclusions could be achieved in 3-4 years. In the first phase, that 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 defined protocol. All patients participating in this trial and all members of investigation team would be completely introduced to plan and aims of this trial.
Two main hypothesis of this trial are that SLNB does not have 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 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 reliable approach for sugical axillary management.
Data would be collected individually for each patient and recorded on appropriated forms. After data completion, leading investigator would import encoded data in register. Data collected in this trial would be used for publications.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
This clinical trial is designed as prospective, observational, non-randomized clinical trial of overall duration of 8-9 years, 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 tumor dimensions, pathological report of core needle biopsy, ultrasound evaluation of axillary lymph nodes and cytologicaly proven positive lymph nodes, patients would be divided in three predefined groups and would undergo through 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 afterward by adjuvant oncological treatment. Before neoadjuvant treatment all patients would undergo magnetic resonance (MR) imaging and ultrasound guided placement titanium clip in primary tumor site. Clinical assessment of effectiveness of neoadjuvant treatment would be evaluate by breast MR imaging in the middle and at the end of the neoadjuvant systemic treatment.
Group 3 (T1-3 N1-2 M0) protocol include the Group 2 protocol in addition with FNA (cytology) prove 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 presence of any size residual tumor in lymph node(s) in group 2 and 3 axillary lymph node dissection would be made.
All patients would be controlled periodically in postoperative five years follow up period to determine the prevalence of locoregional recurrence, progression of disease to M1 stage and overall survival rate.
The results would be compared among groups, to available literature data and to our former data of patients of same stage but treated in period from 2011 till 2014 (i.e. without neoadjuvant therapy).
In addition, all marked nodes (group 3) would be examined for presence or absence of intraoperative signal and presence or absence of any residual tumor.
In the first phase, that 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 last 30 patients in each group.
All patients participating in this trial and all members of investigation team would be completely introduced to plan and aims of this trial.
Two main hypothesis of this trial are that SLNB does not have 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 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 reliable approach for sugical axillary management and that does not have negative impact on the oncological principles and clinical outcome.
Data would be collected individually for each patient during diagnostic and therapeutic period and in follow up period (periodic ambulance controls) for 5 postoperative years.
Data would be recorded on appropriated forms. After data completion, leading investigator would import encoded data in register. All data would be available to all members of 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1-control group-T1-T2 N0 M0 Breast cancer patients in T1 N0 M0 stage at time of diagnose who initial undergo surgical treatment (quadrantectomy/mastectomy + sentinel lymph node biopsy). All patients will be followed for 5 years after surgery |
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| 2-T2-T3 N0 M0 Breast cancer patients in T2-T3 N0 M0 stage at time of diagnose who undergo neoadjuvant oncological treatment followed by surgery (quadrantectomy/mastectomy + sentinel lymph node biopsy). For presence of any residual tumor in lymph node(s) at final pathology report, ALND would be made. All patients will be followed for 5 years after surgery |
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| 3-T1-T3 N1-N2 M0 Breast cancer patients in T1-T3 N1-N2 M0 stage at time of diagnose who undergo neoadjuvant oncological treatment followed by ultrasound reevaluation of axillary lymph nodes that indicate complete clinical axillary remission. 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 titanium clip and at the time of surgery removed and pathological examined regardless presenting as a sentinel node or not. For presence of any residual tumor in lymph node(s) at final pathology report, ALND would be made All patients will be followed for 5 years after surgery |
Outcome Measures
Primary Outcome Measures
- Impact of sentinel lymph node biopsy procedure on locoregional recurrence for group 3 sentinel node negative patients [5 postoperative years]
Locoregional recurrence for group 3 sentinel node negative patients compared to group 1 and 2, to our former data and literature data
- Correlation of sentinel node negative patients from group 3 patients and overall survival [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 [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)
Secondary Outcome Measures
- Evaluate if identification and biopsy of pre-neoadjuvant proven positive lymph node increase the reliability of sentinel lymph node biopsy after neoadjuvant treatment in patients that achieve complete clinical remission of axillary lymph nodes [3,5 years (recruiting period)]
All nodes marked with titanium clip will be evaluated due to presence or absence of signal regardless being positive or negative Correspondence rate between marked node and sentinel node would be calculated Correspondence rate between non-sentinel node and marked node that is positive on final pathology report would be calculated
- Evaluate the correlations of axillary response to neoadjuvant treatment and pathological characteristic of tumor [3,5 years (recruiting period)]
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
- Evaluate accuracy of axillary ultrasound after neoadjuvant treatment (overall and related to tumor subtypes) [3.5 years]
Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of axillary ultrasound after neoadjuvant treatment
- Evaluate accuracy of standard breast MR imaging in axillary lymph node evaluation after neoadjuvant treatment (overall and related to tumor subtypes) [3.5 years]
Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of breast MR imaging in evaluation of axillary lymph nodes after neoadjuvant treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients must be female
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Patients must be older then 18 years of age and younger of 80 years of age
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Patents must have biopsy proven breast cancer, histological type-ductal, immunophenotype-Luminal B, HER-2 positive and triple negative
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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
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Patients treated (oncological and surgical) in Clinical Hospital Centar Rijeka from September 2018 till May 2022
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Patients must be in stage cT1-3 cN0-2 cM0 at the time of diagnosis and cN0 at the time of the surgery
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Patients that are eligible for neoadjuvant oncological treatment, accepting to undergo it and complete it
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Patients that understand, accept and have signed the approved consent form
Exclusion Criteria:
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Patents in T4 stage and/or N3 stage and/or M1 stage at the time of diagnosis
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Patients with inflamatory carcinoma
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Patients with bilateral disease
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Patients with ipsilateral reccurence
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Patients with histological type-lobular and immunophenotype-Luminal A
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Patients that are not eligible for oncological treatment according to protocol, either neoadjuvant or adjuvant, or oncological treatment was interrupted (aborted or completed in other institution)
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Patients that have had previously SLNB or ALND or radiotherapy to the axillary nodes
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Patients that have been or are treated from other malignant disease
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Patients with hypersensitivity or allergy to radiocolloid
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Patients without complete documentation required for this study
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Pregnant patients
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Psychiatric patients
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Male patients
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ana Car Peterko | Rijeka | Croatia | 51000 |
Sponsors and Collaborators
- Clinical Hospital Center Rijeka
Investigators
- Principal Investigator: Ana Car Peterko, Clinical Hospital Centar Rijeka
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SLNB-ACP