Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node

Summary

The recently randomized trial (ASCOG Z0011) support that among patients with limited sentinel lymph node (SLN) metastatic breast cancer treated with breast conservation and systemic therapy, the use of sentinel lymph node biopsy (SLNB) alone compared with axillary lymph node dissection (ALND) did not result in inferior survival. These patients, therefore, are unlikely to benefit from further surgery that results in a longer period of hospitalization, higher costs and higher postoperative morbidity. This result has been written in the 2012 National Comprehensive Cancer Network Clinical Practice Guidelines.

However, Limitations of Z0011, such as failure to achieve target accrual and possible randomization imbalance favoring the SLNB-alone group, must be considered. In the other hand, further testing in different country are needed.

The investigators design and begin a prospective randomized multicenter phase III study of ALND vs. no ALND in breast Cancer with positive SLN--the validation of Z0011 in China.

Conditions

• Breast Cancer

Interventions

PROCEDURE

Sentinel Lymph Node Biopsy

Sentinel lymph nodes are identified with the combining use of intraoperative gamma detector and/or blue dye.

PROCEDURE

Intraoperative Pathological Examination

touch imprint cytology and/or frozen section and/or OSNA

PROCEDURE

Axillary Lymph Node Dissection

Axillary lymph node dissection involving removal of at least level I and II nodes.

PROCEDURE

Pathological Evaluation

H\&E and IHC

DRUG

Adjuvant Systemic Therapy

Adjuvant systemic therapy was determined by the treating physician according to the recently NCCN.

RADIATION

Radiation Therapy

Whole-breast opposing tangential-field radiation therapy.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute

  lead OTHER

Principal Investigators

• Yong-sheng Wang, MD · Shandong Cancer Hospital and Institute

• Tao Ouyang, MD · Beijing Cancer Hospital and Institute

• Jiong Wu, MD · Fudan University

• Feng-xi Su, MD · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

• Hong-yuan Li, MD · First Affiliated Hospital of Chongqing Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2025-12-31

Completion

2026-06-30

Countries

• China

Study Locations