A Prospective Validation Cohort Study of a Prediction System on nSLN Metastasis in Early Breast Cancer

Study Overview
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Brief Summary
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In the previous study, the investigator established a predictive model for non-sentinel lymph node involvement in early breast cancer (cT1-2cN0, 1-2 SLNs involvement). To validation the clinical value of the model, the investigator design a prospectively research using the model guiding for further axillary lymph node dissection in SLN-positve early breast cancer.

Detailed Description
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In the previous study, a predictive model for non-sentinel lymph node involvement in early breast cancer (cT1-2cN0, 1-2 SLNs involvement) was established. This model was designed for predicting the status of non-sentinel lymph node in cT1-2cN0 with 1-2 SLNs involvement breast cancer based on peripheral blood CK19 and contrast-enhanced ultrasound. The investigator previously tested this model comparing with MSKCC model in a same population and confirmed a result of satisfactory low false-negative rate and high AUC. This model had a potential practise value in clinic applying. For further validation, the research group design the CK19B trial to prospectively using this model in decision strategy of whether receiving ALND in 1-2SLNs+ patients. If the model predictive result is negative, the risk of nSLNs involvement is estimated very low and the patients should be avoid ALND, even radiotherapy no matter the surgery is mastectomy or conserving. If the model result is positive, then further ALND or radiotherapy should be accepted by patients to decrease the risk of local and regional recurrent. A prospectively and conditional grouping method is planned for this cohort study. The primary endpoint is disease-free survival (DFS) in two groups, the second primary endpoint is local recurrent rate (LRR) and overall survival (OS).

Official Title
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CK19 Combined With Contrast-enhanced Ultrasound for Predicting Non-sentinel Lymph Node Status in Early Breast Cancer: a Prospectively Validation Cohort Study of the Predictive Model

Conditions
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Lymph Node Metastases, Breast Cancer, Predictive Cancer Model

Intervention / Treatment
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* Procedure: axillary lymph node dissection (ALND)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the test group should be in accordance with the pathological diagnosis of breast cancer, the clinical stage of breast cancer (stage cTis, cI, cII and cT3N1M0), the initial treatment to receive surgical treatment. Complete preoperative clinical diagnosis data, including the ipsilateral axillary lymph node CEUS data and peripheral blood sample; The negative-control group should comply with the pathological diagnosis, breast adenosis, fibrocystic lesions, breast cysts and other benign lesions, with complete preoperative clinical data, also including ipsilateral axillary lymph node CEUS data and peripheral blood sample Exclusion Criteria: metastatic breast cancer, inflammatory breast disease, surgery without lymph node staging pregnancy or lactation patients with hematopoietic system disease or cancer, autoimmune diseases preservation of substandard peripheral blood samples.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study based on prospective cohort method and concerning on the two groups (whether ALND or not) by predictive model nSLN results.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: predictive nSLN-<br>No further axillary lymph node dissection (ALND) | |
| Active Comparator: predictive nSLN+<br>axillary lymph node dissection (ALND) | Procedure: axillary lymph node dissection (ALND)<br>* If the patients had predictive nSLN+, need further axillary lymph node dissection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival (DFS) | The time from enrollment to the first recurrent or metastasis event | 3-year(mid-term) 5-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local recurrent rate | The time from enrollment to the first time of local recurrent event (lymph drainage area recurrence) | 3-year(mid-term) 5-year | 
| overal survival (OS) | The time from enrollment to death for any reason | 3-year(mid-term) 5-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-sentinel lymph node, breast cancer, prediction, CK19, contrast-enhanced ultrasound