Breast Cancer
Conditions
Brief summary
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.
Interventions
PROCEDURESLNB is spared
SLNB is spared in patients with negative preoperative axillary assessment(including LymphPET and other imaging examinations)
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
stage 1: 1. female 2. ≥18 years old 3. invasive ductal carcinoma or DCIS proved by core needle biopsy 4. tumor size ≤ 5cm 5. negative preoperative axillary assessment(including body examination, ultrasound and MR examination) 6. patients is accessible for the following axillary surgery and pathological test(including sentinel lymph node biopsy and axillary lymph node dissection) stage 2: 1. female 2. ≥18 years old 3. invasive carcinoma proved by core needle biopsy 4. has plan for breast conserving surgery and adjuvant radiation after surgery 5. negative preoperative axillary assessment(including body examination, ultrasound and axillary PET mSUV\<0.27) 6. patients is accessible for the follow up
Exclusion criteria
stage 1: 1. distant metastases 2. in the procedure of neoadjuvant therapy 3. positive preoperative axillary assessment (including body examination, ultrasound and MR examination) 4. pregnancy or breastfeeding 5. axillary biopsy or axillary surgery before LymphPET 6. suffer from diabetes mellitus and without well control of bloodglucose 7. previous malignancy 8. allergic to tracer of LymphPET stage 2: 1. distant metastases 2. in the procedure of neoadjuvant therapy 3. positive preoperative axillary assessment (including body examination, ultrasound and PET mSUV≥0.27) 4. pregnancy or breastfeeding 5. axillary biopsy or axillary surgery before LymphPET 6. suffer from diabetes mellitus and without well control of bloodglucose 7. previous malignancy 8. allergic to tracer of LymphPET
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| stage 1: negative predictive value | 6 months | negative predictive value of LymphPET in breast cancer patients with a negative preoperative axillary assessment |
| stage 2: D-DFS(distant disease-free survival) | 5 years | D-DFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared |
| stage 2: LRFS(local-regional free survival) | 5 years | LRFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| stage 2: adverse events of upper limbs | 5 years | 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 |
| stage 1: false negative rate | 6 months | false negative rate of LymphPET in breast cancer patients with a negative preoperative axillary assessment |
| stage 2: breast self evaluation | 5 years | 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. |
| stage 2: DFS(disease-free survival) | 5 years | DFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared |
| stage 2: OS(overall survival) | 5 years | OS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared |
Countries
China
Contacts
Primary ContactZhi-Min Shao
Outcome results
None listed