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

Tao OUYANG

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Procedure: Wire-localized abnormal node

Study type: Interventional

Funder types: Other

Identifiers

NCT02005926

BCP07

Details and patient eligibility

About

• 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.

Enrollment: 200 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

negative FNA result of abnormal node

Experimental group

Description:

Axillary ultrasound examination was undergone for all breast cancer patients before sentinel lymph node biopsy (SLNB). If abnormal axillary lymph node was found, ultrasound-guided FNA cytology of these nodes were performed. The abnormal nodes were defined as completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation and cortical thickness \>3mm. Patients with negative results of FNA would undergo SLNB. Technetium-99m-labeled Rituximab was used for lymphatic mapping. Before the SLNB operation, a hookwire was placed at the suspicious axillary lymph node by ultrasound guidance. In the SLNB operation, radioactive nodes and wire-localized nodes were removed and labeled separately for pathological examination.

Treatment:

Procedure: Wire-localized abnormal node