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

NCT ID: NCT01796444

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2026-06-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Sentinel Lymph Node Biopsy

Intervention Type: PROCEDURE

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

Intraoperative Pathological Examination

Intervention Type: PROCEDURE

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

Axillary Lymph Node Dissection

Intervention Type: PROCEDURE

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

Pathological Evaluation

Intervention Type: PROCEDURE

H\&E and IHC

Adjuvant Systemic Therapy

Intervention Type: DRUG

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

Radiation Therapy

Intervention Type: RADIATION

Whole-breast opposing tangential-field radiation therapy.

Non-Axillary Lymph Node Dissection

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.

Group Type: EXPERIMENTAL

Sentinel Lymph Node Biopsy

Intervention Type: PROCEDURE

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

Intraoperative Pathological Examination

Intervention Type: PROCEDURE

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

Pathological Evaluation

Intervention Type: PROCEDURE

H\&E and IHC

Adjuvant Systemic Therapy

Intervention Type: DRUG

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

Radiation Therapy

Intervention Type: RADIATION

Whole-breast opposing tangential-field radiation therapy.

Interventions

Sentinel Lymph Node Biopsy

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

Intervention Type: PROCEDURE

Intraoperative Pathological Examination

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

Intervention Type: PROCEDURE

Axillary Lymph Node Dissection

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

Intervention Type: PROCEDURE

Pathological Evaluation

H\&E and IHC

Intervention Type: PROCEDURE

Adjuvant Systemic Therapy

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

Intervention Type: DRUG

Radiation Therapy

Whole-breast opposing tangential-field radiation therapy.

Intervention Type: RADIATION

Other Intervention Names

SLNB; ALND; chemotherapy or hormone therapy

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: lead

Responsible Party

Yongsheng Wang

Director, Head of Breast Cancer Center, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong-sheng Wang, MD

Role: STUDY_CHAIR

Shandong Cancer Hospital and Institute

Tao Ouyang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Cancer Hospital and Institute

Jiong Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Feng-xi Su, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Hong-yuan Li, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Chongqing Medical University

Locations

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Countries

China

Other Identifiers

Z0011-China

Identifier Type: -

Identifier Source: org_study_id