Sentinel Node Biopsy Vs Observation After Axillary PET

NCT04072653 | Recruiting DMC

• 1 other identifier: SCHBCC-SOAPET
• Study Type: interventional
• Target: 1,528
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• stage 1: negative predictive value

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

  6 months

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

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

  5 years

• stage 2: LRFS(local-regional free survival)

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

  5 years

Secondary Outcomes (5)

• stage 1: false negative rate

  6 months

• stage 2: DFS(disease-free survival)

  5 years

• stage 2: OS(overall survival)

  5 years

• stage 2: adverse events of upper limbs

  5 years

• stage 2: breast self evaluation

  5 years

Study Arms (1)

Observation group( SLNB is spared)

EXPERIMENTAL

In the second stage, sentinel lymph node biopsy will be spared in the patients with negative preoperative axillary assessment.

Procedure: SLNB is spared

Interventions

SLNB is spared PROCEDURE

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

Observation group( SLNB is spared)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhi-Min Shao

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi-Min Shao

CONTACT

086-021-64175590; zhimingshao@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: September 4, 2019
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)