The Accuracy of Sentinel Node Biopsy of Breast Cancer With Sonographic Abnormal Axillary Lymph Nodes

Breast Cancer Clinical Trial

Official title:

Phase II Trail of Removing Sonographic Abnormal Lymph Node in Sentinel Lymph Node Biopsy of Breast Cancer Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005926
• Other study ID #: BCP07
• Status: Completed
• Phase: Phase 2
• First received: December 4, 2013
• Last updated: June 16, 2014
• Start date: May 2010
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

• This is a phase II, prospective, single-center, non-randomized, non-controlled study.

• Sentinel lymph node biopsy (SNB) is a standard staging procedure in early breast cancer. The potentially increasing false negative rate of SNB was concerned if the sonographic abnormal node was not excised. The aim of this study was to evaluate the accuracy of SNB in breast cancer with sonographic abnormal axillary lymph nodes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• histologically confirmsed primary breast cancer by core neelde biopsy or excisional biospy

• abnormal axillary lymph node was found by ultrasound examination before SLNB (abnormal nodes were defined as completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation and cortical thickness >3mm)

• ultrasound-guided FNA cytology of these nodes were performed

• the result of FNA cytology was negative (no tumour cell was found)

• patient planed to perform SLNB

Exclusion Criteria:

• pathological diagnosed ductal carcinoma in situ by excisional biospy

• abnormal axillary lymph node was found by ultrasound examination but FNA cytology of these nodes were not performed

• the result of FNA cytology was positive (tumour cell was found)

• T4d tumour

• patient has recieved neo-adjuvant system therapy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Wire-localized abnormal node
Before the sentinel lymph node biopsy (SLNB) operation, a hookwire was placed at the suspicious axillary lymph node by ultrasound guidance to localize the abnormal node. In the SLNB operation, radioactive nodes and wire-localized nodes were removed and labeled separately for pathological examination.

Locations

Country	Name	City	State
China	Breast cancer, Peking University Cancer Hospital & Institute	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Tao OUYANG

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	False negative rate of sentinel node biopsy if sonographic abnormal node not be removed		one week after sentinel node biopsy	No