Clinical trial NCT04072653: Sentinel Node Biopsy Vs Observation After Axillary PET
Official title: Sentinel Node Biopsy Vs Observation After Axillary PET Examination
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 1528
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: stage 1: negative predictive value
timeFrame: 6 months
measure: stage 2: D-DFS(distant disease-free survival)
timeFrame: 5 years
measure: stage 2: LRFS(local-regional free survival)
timeFrame: 5 years
Secondary outcomes:
measure: stage 1: false negative rate
timeFrame: 6 months
measure: stage 2: DFS(disease-free survival)
timeFrame: 5 years
measure: stage 2: OS(overall survival)
timeFrame: 5 years
measure: stage 2: adverse events of upper limbs
timeFrame: 5 years
measure: stage 2: breast self evaluation
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhi-Min Shao
role: PRINCIPAL_INVESTIGATOR
References: