Clinical trial NCT01796444: Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer
Sentinel Lymph Node Biopsy
Axillary Lymph Node Dissection
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2013-02-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Disease Free Survival
timeFrame: Time to relapse or progression up to 10 years
Secondary outcomes:
measure: Overall Survival
timeFrame: Time to death up to 10 years
measure: Axillary Recurrence Rate
timeFrame: Time to local relapse up to 10 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Yong-sheng Wang, MD
role: STUDY_CHAIR
affiliation: Beijing Cancer Hospital and Institute
name: Tao Ouyang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Jiong Wu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Feng-xi Su, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Hong-yuan Li, MD
role: PRINCIPAL_INVESTIGATOR
References: