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

Phase 3

Withdrawn

• Conditions: Breast Cancer
• Interventions: Procedure: Sentinel Lymph Node Biopsy; Procedure: Intraoperative Pathological Examination; Procedure: Pathological Evaluation; Procedure: Axillary Lymph Node Dissection; Drug: Adjuvant Systemic Therapy; Radiation: Radiation Therapy

• Registration Number: NCT01796444
• Lead Sponsor: Shandong Cancer Hospital and Institute

Brief 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.

Detailed Description

OBJECTIVES:

To determine the effects of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer.

OUTLINE: This is a randomized multicenter study. Before randomization, all women were stratified according to age (≤50 years, \>50 years), tumor size(≤2cm, \>2cm) and research center. All the patients underwent lumpectomy and sentinel lymph node biopsy (SLNB). Eligible women were randomly assigned to ALND or no ALND Active Comparator: Patients undergo axillary lymph node dissection involving removal of at least level I and II nodes.

Experimental: No surgery of axillary lymph node in this arm. All the patients were to receive whole-breast opposing tangential-field radiation therapy. The use of adjuvant systemic therapy was determined by the treating physician according to the recently NCCN.

Patients are followed up every 4 months for the first 2 years, every 6 months from the third year to the fifth year, and then annually for a total of 10 years.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-19
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-21
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Axillary Lymph Node Dissection	Pathological Evaluation	After sentinel lymph node biopsy, no surgery of axillary lymph node In this study, the absence of surgery is the experimental arm (non-inferiority trial). Pathological evaluation (include intraoperative pathological examination) is performed routinely. All women were to receive whole-breast opposing tangential-field radiation therapy. Adjuvant systemic therapy was determined by the treating physician.
Non-Axillary Lymph Node Dissection	Adjuvant Systemic Therapy	After sentinel lymph node biopsy, no surgery of axillary lymph node In this study, the absence of surgery is the experimental arm (non-inferiority trial). Pathological evaluation (include intraoperative pathological examination) is performed routinely. All women were to receive whole-breast opposing tangential-field radiation therapy. Adjuvant systemic therapy was determined by the treating physician.
Non-Axillary Lymph Node Dissection	Radiation Therapy	After sentinel lymph node biopsy, no surgery of axillary lymph node In this study, the absence of surgery is the experimental arm (non-inferiority trial). Pathological evaluation (include intraoperative pathological examination) is performed routinely. All women were to receive whole-breast opposing tangential-field radiation therapy. Adjuvant systemic therapy was determined by the treating physician.
Axillary Lymph Node Dissection	Sentinel Lymph Node Biopsy	After sentinel lymph node biopsy, surgery for standard axillary lymph node dissection. Pathological evaluation (include intraoperative pathological examination) is performed routinely. All women were to receive whole-breast opposing tangential-field radiation therapy. Adjuvant systemic therapy was determined by the treating physician.
Axillary Lymph Node Dissection	Intraoperative Pathological Examination	After sentinel lymph node biopsy, surgery for standard axillary lymph node dissection. Pathological evaluation (include intraoperative pathological examination) is performed routinely. All women were to receive whole-breast opposing tangential-field radiation therapy. Adjuvant systemic therapy was determined by the treating physician.
Axillary Lymph Node Dissection	Axillary Lymph Node Dissection	After sentinel lymph node biopsy, surgery for standard axillary lymph node dissection. Pathological evaluation (include intraoperative pathological examination) is performed routinely. All women were to receive whole-breast opposing tangential-field radiation therapy. Adjuvant systemic therapy was determined by the treating physician.
Axillary Lymph Node Dissection	Pathological Evaluation	After sentinel lymph node biopsy, surgery for standard axillary lymph node dissection. Pathological evaluation (include intraoperative pathological examination) is performed routinely. All women were to receive whole-breast opposing tangential-field radiation therapy. Adjuvant systemic therapy was determined by the treating physician.
Axillary Lymph Node Dissection	Adjuvant Systemic Therapy	After sentinel lymph node biopsy, surgery for standard axillary lymph node dissection. Pathological evaluation (include intraoperative pathological examination) is performed routinely. All women were to receive whole-breast opposing tangential-field radiation therapy. Adjuvant systemic therapy was determined by the treating physician.
Axillary Lymph Node Dissection	Radiation Therapy	After sentinel lymph node biopsy, surgery for standard axillary lymph node dissection. Pathological evaluation (include intraoperative pathological examination) is performed routinely. All women were to receive whole-breast opposing tangential-field radiation therapy. Adjuvant systemic therapy was determined by the treating physician.
Non-Axillary Lymph Node Dissection	Sentinel Lymph Node Biopsy	After sentinel lymph node biopsy, no surgery of axillary lymph node In this study, the absence of surgery is the experimental arm (non-inferiority trial). Pathological evaluation (include intraoperative pathological examination) is performed routinely. All women were to receive whole-breast opposing tangential-field radiation therapy. Adjuvant systemic therapy was determined by the treating physician.
Non-Axillary Lymph Node Dissection	Intraoperative Pathological Examination	After sentinel lymph node biopsy, no surgery of axillary lymph node In this study, the absence of surgery is the experimental arm (non-inferiority trial). Pathological evaluation (include intraoperative pathological examination) is performed routinely. All women were to receive whole-breast opposing tangential-field radiation therapy. Adjuvant systemic therapy was determined by the treating physician.

Primary Outcome Measures

Name	Time	Method
Disease Free Survival	Time to relapse or progression up to 10 years	Time from randomization to relapse or death.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Time to death up to 10 years	Time from randomization to date of death.
Axillary Recurrence Rate	Time to local relapse up to 10 years	Estimate the incidence of axillary recurrence after surgery followed by axillary dissection or after surgery alone.

Trial Locations

Locations (1)

Shandong Cancer Hospital and Institute; 🇨🇳 Jinan, Shandong, China