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NCT Number: NCT04072653

Sentinel Node Biopsy Vs Observation After Axillary PET

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Zhiming Shao

CONTACT

+86-021-64175590

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SLNB is spared

Procedure

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

Primary outcomes

  1. stage 1: negative predictive value

    Time frame: 6 months

    negative predictive value of LymphPET in breast cancer patients with a negative preoperative axillary assessment

  2. stage 2: D-DFS(distant disease-free survival)

    Time frame: 5 years

    D-DFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared

  3. stage 2: LRFS(local-regional free survival)

    Time frame: 5 years

    LRFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared

Secondary outcomes

  1. stage 1: false negative rate

    Time frame: 6 months

    false negative rate of LymphPET in breast cancer patients with a negative preoperative axillary assessment

  2. stage 2: DFS(disease-free survival)

    Time frame: 5 years

    DFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared

  3. stage 2: OS(overall survival)

    Time frame: 5 years

    OS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared

  4. stage 2: adverse events of upper limbs

    Time frame: 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

  5. stage 2: breast self evaluation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhi-Min Shao

CONTACT

[email protected]

086-021-64175590

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Sentinel Node Biopsy Vs Observation After Axillary PET Examination

Acronym: SOAPET

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2019
Registry last updated
Jul 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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