Breast CancerPhase 3Z0011-ChinaNCT01796444
Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node
A Phase 3 study testing Sentinel Lymph Node Biopsy, Intraoperative Pathological Examination and Axillary Lymph Node Dissection in people with Breast Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Sentinel Lymph Node Biopsy, Intraoperative Pathological Examination and Axillary Lymph Node Dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Sentinel Lymph Node Biopsy, Intraoperative Pathological Examination, Axillary Lymph Node Dissection, Pathological Evaluation, Adjuvant Systemic Therapy
- Keywords
- Breast Cancer, Sentinel Lymph Node Biopsy, Axillary Lymph Node Dissection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Lymph Node BiopsyProcedure or surgery
Also called SLNB
Sentinel lymph nodes are identified with the combining use of intraoperative gamma detector and/or blue dye.
Intraoperative Pathological ExaminationProcedure or surgery
touch imprint cytology and/or frozen section and/or OSNA
Axillary Lymph Node DissectionProcedure or surgery
Also called ALND
Axillary lymph node dissection involving removal of at least level I and II nodes.
Pathological EvaluationProcedure or surgery
H\&E and IHC
Adjuvant Systemic TherapyDrug
Also called chemotherapy or hormone therapy
Adjuvant systemic therapy was determined by the treating physician according to the recently NCCN.
Radiation TherapyRadiation
Whole-breast opposing tangential-field radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sentinel Lymph Node Biopsy; Procedure: Intraoperative Pathological Examination; Procedure: Pathological Evaluation; Drug: Adjuvant Systemic Therapy; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival
Time from randomization to relapse or death.
Measured: Time to relapse or progression up to 10 years
Secondary outcomes (2)
Overall Survival
Time from randomization to date of death.
Measured: Time to death up to 10 years
Axillary Recurrence Rate
Estimate the incidence of axillary recurrence after surgery followed by axillary dissection or after surgery alone.
Measured: Time to local relapse up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongsheng Wang, Shandong Cancer Hospital and Institute
- Investigators
- Yong-sheng Wang, MD, Study chair, Shandong Cancer Hospital and InstituteTao Ouyang, MD, Principal investigator, Beijing Cancer Hospital and InstituteJiong Wu, MD, Principal investigator, Fudan UniversityFeng-xi Su, MD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityHong-yuan Li, MD, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796444
- Sponsor's protocol ID
- Z0011-China
- Acronym
- Z0011-China
- Status last verified
- Apr 2018
- First submitted
- 19 Feb 2013
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01796444
- Acronym / sponsor ID
- Z0011-China / Z0011-China
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Sentinel Lymph Node Biopsy, Axillary Lymph Node Dissection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axillary Lymph Node Dissection | Active comparator | Procedure: Sentinel Lymph Node Biopsy, Procedure: Intraoperative Pathological Examination, Procedure: Axillary Lymph Node Dissection, Procedure: Pathological Evaluation, Drug: Adjuvant Systemic Therapy, Radiation: Radiation TherapyAfter 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. |
| Non-Axillary Lymph Node Dissection | Experimental | Procedure: Sentinel Lymph Node Biopsy, Procedure: Intraoperative Pathological Examination, Procedure: Pathological Evaluation, Drug: Adjuvant Systemic Therapy, Radiation: Radiation TherapyAfter 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel Lymph Node BiopsyAlso: SLNBSentinel lymph nodes are identified with the combining use of intraoperative gamma detector and/or blue dye. | Procedure or surgery | Axillary Lymph Node Dissection, Non-Axillary Lymph Node Dissection |
| Intraoperative Pathological Examinationtouch imprint cytology and/or frozen section and/or OSNA | Procedure or surgery | Axillary Lymph Node Dissection, Non-Axillary Lymph Node Dissection |
| Axillary Lymph Node DissectionAlso: ALNDAxillary lymph node dissection involving removal of at least level I and II nodes. | Procedure or surgery | Axillary Lymph Node Dissection |
| Pathological EvaluationH\&E and IHC | Procedure or surgery | Axillary Lymph Node Dissection, Non-Axillary Lymph Node Dissection |
| Adjuvant Systemic TherapyAlso: chemotherapy or hormone therapyAdjuvant systemic therapy was determined by the treating physician according to the recently NCCN. | Drug | Axillary Lymph Node Dissection, Non-Axillary Lymph Node Dissection |
| Radiation TherapyWhole-breast opposing tangential-field radiation therapy. | Radiation | Axillary Lymph Node Dissection, Non-Axillary Lymph Node Dissection |
Primary outcome
Disease Free Survival
Time frame: Time to relapse or progression up to 10 years
Time from randomization to relapse or death.
2 secondary outcomes
Overall Survival
Time frame: Time to death up to 10 years
Axillary Recurrence Rate
Time frame: Time to local relapse up to 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong-sheng Wang, MD study chair
Shandong Cancer Hospital and Institute
Tao Ouyang, MD principal investigator
Beijing Cancer Hospital and Institute
Jiong Wu, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sentinel Lymph Node Biopsy, Intraoperative Pathological Examination and Axillary Lymph Node Dissection in people with Breast Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (time frame: Time to relapse or progression up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.