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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,528
SLNB is spared in patients with negative preoperative axillary assessment(including LymphPET and other imaging examinations)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGstage 1: negative predictive value
negative predictive value of LymphPET in breast cancer patients with a negative preoperative axillary assessment
Time frame: 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
Time frame: 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
Time frame: 5 years
stage 1: false negative rate
false negative rate of LymphPET in breast cancer patients with a negative preoperative axillary assessment
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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.
Time frame: 5 years