Breast Cancer Clinical Trial
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
Verified date | December 2023 |
Source | Clinical Hospital Center Rijeka |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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 | Active, not recruiting |
Enrollment | 230 |
Est. completion date | May 2027 |
Est. primary completion date | May 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | 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 hypersensitivity or allergy to radiocolloid - Patients without complete documentation required for this study - Pregnant patients - Psychiatric patients - Male patients |
Country | Name | City | State |
---|---|---|---|
Croatia | Ana Car Peterko | Rijeka |
Lead Sponsor | Collaborator |
---|---|
Clinical Hospital Center Rijeka |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | 4 years | |
Secondary | 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 | 4 years |
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