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

NCT01796444 | Withdrawn Phase 3

• 1 other identifier: Z0011-China
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Sentinel Lymph Node Biopsy; Axillary Lymph Node Dissection

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival

  Time from randomization to relapse or death.

  Time to relapse or progression up to 10 years

Secondary Outcomes (2)

• Overall Survival

  Time to death up to 10 years

• Axillary Recurrence Rate

  Time to local relapse up to 10 years

Study Arms (2)

Axillary Lymph Node Dissection

ACTIVE COMPARATOR

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.

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

Non-Axillary Lymph Node Dissection

EXPERIMENTAL

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.

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

Interventions

Sentinel Lymph Node Biopsy PROCEDURE

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

Also known as: SLNB

Axillary Lymph Node Dissection; Non-Axillary Lymph Node Dissection

Intraoperative Pathological Examination PROCEDURE

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

Axillary Lymph Node Dissection; Non-Axillary Lymph Node Dissection

Axillary Lymph Node Dissection PROCEDURE

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

Also known as: ALND

Axillary Lymph Node Dissection

Pathological Evaluation PROCEDURE

H\&E and IHC

Axillary Lymph Node Dissection; Non-Axillary Lymph Node Dissection

Adjuvant Systemic Therapy DRUG

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

Also known as: chemotherapy or hormone therapy

Axillary Lymph Node Dissection; Non-Axillary Lymph Node Dissection

Radiation Therapy RADIATION

Whole-breast opposing tangential-field radiation therapy.

Axillary Lymph Node Dissection; Non-Axillary Lymph Node Dissection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sentinel Lymph Node Biopsy; Drug Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques; Therapeutics

Study Officials

• Yong-sheng Wang, MD

  Shandong Cancer Hospital and Institute

  STUDY CHAIR

• Tao Ouyang, MD

  Beijing Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

• Jiong Wu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Feng-xi Su, MD

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

  PRINCIPAL INVESTIGATOR

• Hong-yuan Li, MD

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Breast Cancer Center, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: February 19, 2013
• First Posted: February 21, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

CN (1)