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Recruiting NCT04072653

Sentinel Node Biopsy Vs Observation After Axillary PET

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SLNB is spared.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Sentinel Node Biopsy Vs Observation After Axillary PET Examination

Overview

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

  • Procedure SLNB is spared
    SLNB is spared in patients with negative preoperative axillary assessment(including LymphPET and other imaging examinations)

Primary outcome measures

  • stage 1: negative predictive value [Time frame: 6 months]
  • stage 2: D-DFS(distant disease-free survival) [Time frame: 5 years]
  • stage 2: LRFS(local-regional free survival) [Time frame: 5 years]
Secondary outcome measures (5)
  • stage 1: false negative rate [Time frame: 6 months]
  • stage 2: DFS(disease-free survival) [Time frame: 5 years]
  • stage 2: OS(overall survival) [Time frame: 5 years]
  • stage 2: adverse events of upper limbs [Time frame: 5 years]
  • stage 2: breast self evaluation [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

stage 1:

  • female
  • ≥18 years old
  • invasive ductal carcinoma or DCIS proved by core needle biopsy
  • tumor size ≤ 5cm
  • negative preoperative axillary assessment(including body examination, ultrasound and MR examination)
  • patients is accessible for the following axillary surgery and pathological test(including sentinel lymph node biopsy and axillary lymph node dissection)

stage 2:

  • female
  • ≥18 years old
  • invasive carcinoma proved by core needle biopsy
  • has plan for breast conserving surgery and adjuvant radiation after surgery
  • negative preoperative axillary assessment(including body examination, ultrasound and axillary PET mSUV<0.27)
  • patients is accessible for the follow up

Exclusion criteria

stage 1:

  • distant metastases
  • in the procedure of neoadjuvant therapy
  • positive preoperative axillary assessment (including body examination, ultrasound and MR examination)
  • pregnancy or breastfeeding
  • axillary biopsy or axillary surgery before LymphPET
  • suffer from diabetes mellitus and without well control of bloodglucose
  • previous malignancy
  • allergic to tracer of LymphPET

stage 2:

  • distant metastases
  • in the procedure of neoadjuvant therapy
  • positive preoperative axillary assessment (including body examination, ultrasound and PET mSUV≥0.27)
  • pregnancy or breastfeeding
  • axillary biopsy or axillary surgery before LymphPET
  • suffer from diabetes mellitus and without well control of bloodglucose
  • previous malignancy
  • allergic to tracer of LymphPET

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Publications

  • Qu FL, Cheng JY, Jiang SH, Zhang Q, Liu GY, Cao AY, Wu J, Yu KD, Di GH, Li JJ, Shao ZM. Omission of Axillary Surgery in Patients with Negative Axillary Evaluation Integrated with LymphPET: A Prospective Clinical Study. Ann Surg Oncol. 2026 Jun;33(6):5558-5566. doi: 10.1245/s10434-026-19342-5. Epub 2026 Feb 27. PMID 41760969

Identifiers

NCT: NCT04072653 · SCHBCC-SOAPET

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗