Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node (Z0011-China)

Shandong First Medical University

Status and phase: Withdrawn; Phase 3

Conditions: Breast Cancer

Treatments: Radiation: Radiation Therapy; Procedure: Pathological Evaluation; Drug: Adjuvant Systemic Therapy; Procedure: Intraoperative Pathological Examination; Procedure: Sentinel Lymph Node Biopsy; Procedure: Axillary Lymph Node Dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT01796444

Z0011-China

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Axillary Lymph Node Dissection

Active Comparator group

Description:

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.

Treatment:

Procedure: Axillary Lymph Node Dissection

Procedure: Pathological Evaluation

Procedure: Intraoperative Pathological Examination

Procedure: Sentinel Lymph Node Biopsy

Drug: Adjuvant Systemic Therapy

Radiation: Radiation Therapy

Non-Axillary Lymph Node Dissection

Experimental group

Description:

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.

Treatment:

Procedure: Pathological Evaluation

Procedure: Intraoperative Pathological Examination

Procedure: Sentinel Lymph Node Biopsy

Drug: Adjuvant Systemic Therapy

Radiation: Radiation Therapy