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

• Status: Withdrawn
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Cancer Hospital and Institute
• Treatments: Hormones

Criteria

Inclusion Criteria:

• Female;

• Patient aged 18 years and above;

• Patient with histological proven invasive breast cancer;

• Clinical T1-T2 disease with no distant metastasis;

• Patient with clinical N0 status;

• Patient for whom conservative surgery with sentinel lymph node (SLN) technique is feasible from the start in terms of carcinologic;

• Patient with positive SLNs 1~2;

• Signed consent to participate.

Exclusion Criteria:

• History of neoadjuvant chemotherapy or hormone therapy;

• History of breast cancer (ipsilateral, i.e. recurrence, or contralateral breast);

• History of any other invasive cancer;

• Initial metastatic disease known;

• Pregnant women or lactating women;

• Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.