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Sentinel Node Biopsy Vs Observation After Axillary PET (SOAPET)

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ClinicalTrials.gov Identifier: NCT04072653
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
Zhimin Shao, Fudan University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: SLNB is spared Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1528 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sentinel Node Biopsy Vs Observation After Axillary PET Examination
Actual Study Start Date : September 4, 2019
Estimated Primary Completion Date : September 1, 2027
Estimated Study Completion Date : September 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Observation group( SLNB is spared)
In the second stage, sentinel lymph node biopsy will be spared in the patients with negative preoperative axillary assessment.
 Procedure: SLNB is spared
SLNB is spared in patients with negative preoperative axillary assessment(including LymphPET and other imaging examinations)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04072653


Contacts
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Contact: Zhi-Min Shao 086-021-64175590 zhimingshao@yahoo.com

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zhiming Shao    +86-021-64175590      
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Zhi-Min Shao Fudan University
More Information
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Responsible Party: Zhimin Shao, professor, Fudan University
ClinicalTrials.gov Identifier: NCT04072653    
Other Study ID Numbers: SCHBCC-SOAPET
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: July 13, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No