Sentinel Node Biopsy Vs Observation After Axillary PET

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: SLNB is spared

• Registration Number: NCT04072653
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-28
• Study Start: 2019-09-04
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-10
• Last Update Posted: 2020-07-13
• Primary Completion: 2027-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1528

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Observation group( SLNB is spared)	SLNB is spared	In the second stage, sentinel lymph node biopsy will be spared in the patients with negative preoperative axillary assessment.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
stage 1: false negative rate	6 months	false negative rate of LymphPET in breast cancer patients with a negative preoperative axillary assessment
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
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 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.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China