Sentinel Node Biopsy Vs Observation After Axillary PET

Study Overview
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Brief Summary
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Several researches have proved that avoiding axillary surgery does not worsen the outcome of breast cancer patients with relatively low risk. Based on the routine axillary imaging evaluation (ultrasound and MR etc.) and latest dedicate lymph node PET (LymphPET), axillary nodal burden can be identified before operation. Therefore this prospective study are designed to evaluate the negative predictive value of LymphPET and to verify whether sentinel lymph node biopsy can be spared in patients with negative preoperative axillary assessment.

Official Title
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Sentinel Node Biopsy Vs Observation After Axillary PET Examination

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: SLNB is spared


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stage 1: female ≥18 years old invasive ductal carcinoma or DCIS proved by core needle biopsy tumor size ≤ 5cm negative preoperative axillary assessment(including body examination, ultrasound and MR examination) patients is accessible for the following axillary surgery and pathological test(including sentinel lymph node biopsy and axillary lymph node dissection) stage 2: female ≥18 years old invasive carcinoma proved by core needle biopsy has plan for breast conserving surgery and adjuvant radiation after surgery negative preoperative axillary assessment(including body examination, ultrasound and axillary PET mSUV<0.27) patients is accessible for the follow up Exclusion Criteria: stage 1: distant metastases in the procedure of neoadjuvant therapy positive preoperative axillary assessment (including body examination, ultrasound and MR examination) pregnancy or breastfeeding axillary biopsy or axillary surgery before LymphPET suffer from diabetes mellitus and without well control of bloodglucose previous malignancy allergic to tracer of LymphPET stage 2: distant metastases in the procedure of neoadjuvant therapy positive preoperative axillary assessment (including body examination, ultrasound and PET mSUV≥0.27) pregnancy or breastfeeding axillary biopsy or axillary surgery before LymphPET suffer from diabetes mellitus and without well control of bloodglucose previous malignancy allergic to tracer of LymphPET

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Interventional Model Description: In the first stage, the negative predictive value is evaluated in patients with negative preoperative axillary assessment, including LymphPET and routine imaging examinations. In the second stage, sentinel lymph node biopsy will be spared in the patients with negative preoperative axillary assessment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Observation group( SLNB is spared)<br>In the second stage, sentinel lymph node biopsy will be spared in the patients with negative preoperative axillary assessment. | Procedure: SLNB is spared<br>* SLNB is spared in patients with negative preoperative axillary assessment(including LymphPET and other imaging examinations)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stage 1: negative predictive value | negative predictive value of LymphPET in breast cancer patients with a negative preoperative axillary assessment | 6 months | 
| stage 2: D-DFS(distant disease-free survival) | D-DFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared | 5 years | 
| stage 2: LRFS(local-regional free survival) | LRFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stage 1: false negative rate | false negative rate of LymphPET in breast cancer patients with a negative preoperative axillary assessment | 6 months | 
| stage 2: DFS(disease-free survival) | DFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared | 5 years | 
| stage 2: OS(overall survival) | OS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared | 5 years | 
| stage 2: adverse events of upper limbs | adverse events of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared，as assessed by CTCAE v5.0 | 5 years | 
| stage 2: breast self evaluation | breast self evaluation for patients with negative preoperative axillary and for whom axillary surgery is spared, as assessed by BREAST Q© index. The BREAST-Q has a modular, procedure-specific structure with scales that evaluate both satisfaction and quality of life. Psychometric evaluation reveals high reliability, validity and responsiveness to surgical intervention across all scales. Breast Q is composed of aesthetical and emotional modules, and each score ranges from 1 to 4 points (higher values represent a better self evaluation). By comparing the sum of the score in different modules before and after the surgery, Breast Q can help to facilitate a self evaluation for breast cancer patients. | 5 years |