Comparison Study of Different Tumor Biopsy Method for Sentinel Lymph Node Biopsy in Breast Cancer

Shandong First Medical University

Status: Unknown

Conditions: Sentinel Lymph Node; Breast Cancer

Treatments: Behavioral: Vacuum-Assisted Biopsy; Behavioral: Intraoperative Excisional Biopsy; Behavioral: Core Needle Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04568941

ShandongCHI-13

Details and patient eligibility

About

Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cance, and the identified number of sentinel lymph nodes determines its accuracy for axillary status. Retrospective study indicated that preoperative tumor biopsy results in more detected sentinel lymoh nodes. The clinical trail is designed to compare the effect of three tumor biopsy methods (preoperative vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy) for sentinel lymph nodes.

Full description

OBJECTIVES:

Compare the identification rate of sentinel lymph node in breast cancer patients with different tumor biopsy methods.

Evaluate the false-negative rates of sentinel lymph nodes in patients with different tumor biopsy methods.

OUTLINE:

The patients were randomly divided into three group, vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy. Preoperative vacuum-assisted biopsy and core needle biopsy were performed in 10 days before the final surgery. All patients received dual tracer (radiolabeled colloid and blue dye) guided SLNB.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinically lymph node negative breast cancer patients T1-T3

Exclusion criteria

• history of breast cancer locally advanced breast cancer and metastatic breast cancer proven axillary lymph node metastasis history of axillary excisional or incisional biopsy, or dissection history of neoadjuvant chemotherapy pregnancy non-consented patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Preoperative Vacuum-Assisted Biopsy

Experimental group

Description:

Preoperative vacuum-assisted biopsy was performed within 10 days before final surgery. The tumor were excised almost.

Treatment:

Behavioral: Vacuum-Assisted Biopsy

Preoperative Core Needle Biopsy

Experimental group

Description:

Preoperative core needle biopsy was performed within 10 days before final surgery. The needle biopsy were performed with 3 needles.

Treatment:

Behavioral: Core Needle Biopsy

Intraoperative Excisional Biopsy

Experimental group

Description:

The tumor was excised intraoperatively.

Treatment:

Behavioral: Intraoperative Excisional Biopsy