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

Breast Cancer Clinical Trial

— Z0011-China  

Official title:

A Prospective Randomized Multicenter Phase III Study of Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node--the Validation of Z0011 in China

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01796444
• Other study ID #: Z0011-China
• Status: Withdrawn
• Phase: Phase 3
• First received: February 19, 2013
• Last updated: April 3, 2018
• Start date: January 2013
• Est. completion date: June 2026

Study information

• Verified date: April 2018
• Source: Shandong Cancer Hospital and Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Sentinel Lymph Node Biopsy
Sentinel lymph nodes are identified with the combining use of intraoperative gamma detector and/or blue dye.
• Intraoperative Pathological Examination
touch imprint cytology and/or frozen section and/or OSNA
• Axillary Lymph Node Dissection
Axillary lymph node dissection involving removal of at least level I and II nodes.
• Pathological Evaluation
H&E and IHC

Drug:
• Adjuvant Systemic Therapy
Adjuvant systemic therapy was determined by the treating physician according to the recently NCCN.

Radiation:
• Radiation Therapy
Whole-breast opposing tangential-field radiation therapy.

Locations

Country	Name	City	State
China	Shandong Cancer Hospital and Institute	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival	Time from randomization to relapse or death.	Time to relapse or progression up to 10 years
Secondary	Overall Survival	Time from randomization to date of death.	Time to death up to 10 years
Secondary	Axillary Recurrence Rate	Estimate the incidence of axillary recurrence after surgery followed by axillary dissection or after surgery alone.	Time to local relapse up to 10 years