Comparing sentinel node biopsy and observation after axillary PET in breast cancer patients

Sentinel Node Biopsy Vs Observation After Axillary PET Examination

This study is testing if breast cancer patients with negative lymph node scans can skip the sentinel lymph node biopsy to see if it’s safe to do so.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1528 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT04072653 on ClinicalTrials.gov

What this trial studies

This study evaluates whether sentinel lymph node biopsy (SLNB) can be avoided in breast cancer patients with negative preoperative axillary assessments using LymphPET imaging. It aims to determine the negative predictive value of LymphPET in identifying axillary nodal burden before surgery. The study focuses on female patients aged 18 and older with specific criteria related to tumor size and type, ensuring they are suitable for follow-up and further surgical procedures if necessary.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 and older with invasive ductal carcinoma or DCIS, negative preoperative axillary assessments, and tumor sizes of 5 cm or less.

Not a fit: Patients with distant metastases, those undergoing neoadjuvant therapy, or those with positive preoperative axillary assessments will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce unnecessary surgical interventions for breast cancer patients, leading to improved quality of life and reduced healthcare costs.

How similar studies have performed: Other studies have indicated that avoiding axillary surgery does not worsen outcomes for low-risk breast cancer patients, suggesting potential success for this approach.

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

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Zhi-Min Shao — Fudan University
• Study coordinator: Zhi-Min Shao

Conditions Breast Cancer