Breast CancerNCT03606616
Prospective Feasibility Study Applying the ACOSOG Z0011 Criteria to Chinese Patients
An observational study of Breast Cancer and Sentinel Lymph Node, run by Peking University People's Hospital at 1 site in China.
Trial summary
In patients undergoing breast-conserving surgery and having positive sentinel lymph nodes (SLNs), the ACOSOG Z0011 trial showed equivalent overall survival(OS) and disease-free survival(DFS) outcomes for patients receiving SLN dissection (SLND) alone and those receiving axillary lymph node dissection (ALND). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Sentinel Lymph Node, Local Recurrence of Malignant Tumor of Breast
- What is being tested?
- no further ALND arm
- Type of treatment
- Surgery or procedure
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2014to 30 Nov 2019
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: histologically confirmed invasive breast cancer patients, who meeting the critiera of Z0011 inclusion: T1 or T2 tumor,1 or 2 positive sentinel lymph nodes,breast-conserving surgery and whole-breast RT planned is enrolled.
Who may be able to join
- histologically confirmed invasive breast cancer T1 or T2 tumor 1 or 2 positive sentinel lymph nodes breast-conserving surgery whole-breast RT planned
Who cannot join
- preoperative therapy 3 or more positive sentinel lymph nodes patients undergoing additional mastectomy due to positive surgical margins
Trial locations and contacts
1 site in 1 country.
China1 site
Peking university people's hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Prospective Feasibility Study Applying the ACOSOG Z0011 Criteria to Chinese Patients With Early Breast Cancer Undergoing Breast-conserving Surgery
In patients undergoing breast-conserving surgery and having positive sentinel lymph nodes (SLNs), the ACOSOG Z0011 trial showed equivalent overall survival(OS) and disease-free survival(DFS) outcomes for patients receiving SLN dissection (SLND) alone and those receiving axillary lymph node dissection (ALND). We conducted a prospective single-arm study to confirm the applicability of the Z0011 criteria to Chinese patients with breast cancer.
Read the detailed description
The American College of Surgeons Oncology Group (ACOSOG) Z0011 trial demonstrated that in clinically node-negative women with T1 or T2 invasive breast cancer, who underwent breast-conserving surgery (BCT) with whole breast irradiation (WBRT), had excellent local control and survival with SLND alone, even if metastases were found in 1 or 2 SLNs. Recently, the long-term follow-up data of the Z0011 study were reported, which demonstrated that the 10-year OS for patients receiving SLND alone was not inferior to that for those receiving ALND.
This breakthrough result of the Z0011 study led to a change in clinical practice regarding the standard management of axillary lymph nodes in patients with breast cancer.
However, these validation data have been generated in Western populations. As the socio-economic profile, life style and culture of Asian are substantially different from those of Western, and genetic backgrounds vary to some extent, it remains unclear whether results similar to those of the Z0011 study could be achieved in a Chinese breast cancer population. In the present study, we prospectively applied the Z0011 eligibility criteria to Chinese patients with clinically node-negative breast cancer undergoing BCT, with planned RT. The purpose of this study is the clinicopathological relevance of the Z0011 findings for Chinese patients with breast cancer, and to verify the feasibility of using the Z0011 criteria to avoid ALND after positive SLN findings.
This is a prospective single-arm study, enrolled patients meeting Z0011 inclusion criteria and providing consent to receive no additional ALND. Overall survival is the primary end point, disease-free survival and occurrence of surgical morbidities a secondary end point.
- Being tested
- no further ALND arm
- Keywords
- ACOSOG Z0011, Chinese breast cancer, sentinel lymph node, overall survival, disease-free survival
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no further ALND armProcedure or surgery
Patients meeting the Z0011 inclusion criteria to receive no additional ALND
| Study group | Role | What they receive |
|---|---|---|
| ACOSOG Z0011 no further ALND arm | patients meeting the criteria for ACOSOG Z0011 trial inclusion：histologically confirmed invasive breast cancer;clinical T1/T2;breast conserving surgery；1 or 2 positive sentinel lymph nodes; Whole-breast RT planned; no preoperative chemotherapy Receives: Procedure: no further ALND arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
the time from surgery until death from any cause
Measured: 5 years
Secondary outcomes (2)
disease-free survival
the time from surgery to death or first documented recurrence of breast cancer
Measured: 5 years
occurrence of surgical morbidities
edema，limited activity or pain on surgical side upper limb
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Nov 2014
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Yuan, Peking University People's Hospital
- Investigators
- shu wang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606616
- Sponsor's protocol ID
- ACOSOGZ0011CH
- Status last verified
- Oct 2022
- First submitted
- 20 Jul 2018
- Last updated
- 18 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peng Y, Liu M, Li X, Tong F, Cao Y, Liu P, Zhou B, Liu H, Cheng L, Guo J, Xie F, Yang H, Wang S, Wang C, Chen Y, Wang S. Application of the ACOSOG Z0011 criteria to Chinese patients with breast cancer: a prospective study. World J Surg Oncol. 2021 Apr 20;19(1):128. doi: 10.1186/s12957-021-02242-1.
PubMed 33879180
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Feasibility Study Applying the ACOSOG Z0011 Criteria to Chinese Patients With Early Breast Cancer Undergoing Breast-conserving Surgery
- ClinicalTrials.gov ID
- NCT03606616
- Acronym / sponsor ID
- ACOSOGZ0011CH
- Keywords
- ACOSOG Z0011, Chinese breast cancer, sentinel lymph node, overall survival, disease-free survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 31 Jul 2018 (actual)
- 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.
In patients undergoing breast-conserving surgery and having positive sentinel lymph nodes (SLNs), the ACOSOG Z0011 trial showed equivalent overall survival(OS) and disease-free survival(DFS) outcomes for patients receiving SLN dissection (SLND) alone and those receiving axillary lymph node dissection (ALND). We conducted a prospective single-arm study to confirm the applicability of the Z0011 criteria to Chinese patients with breast cancer.
Detailed description
The American College of Surgeons Oncology Group (ACOSOG) Z0011 trial demonstrated that in clinically node-negative women with T1 or T2 invasive breast cancer, who underwent breast-conserving surgery (BCT) with whole breast irradiation (WBRT), had excellent local control and survival with SLND alone, even if metastases were found in 1 or 2 SLNs. Recently, the long-term follow-up data of the Z0011 study were reported, which demonstrated that the 10-year OS for patients receiving SLND alone was not inferior to that for those receiving ALND.
This breakthrough result of the Z0011 study led to a change in clinical practice regarding the standard management of axillary lymph nodes in patients with breast cancer.
However, these validation data have been generated in Western populations. As the socio-economic profile, life style and culture of Asian are substantially different from those of Western, and genetic backgrounds vary to some extent, it remains unclear whether results similar to those of the Z0011 study could be achieved in a Chinese breast cancer population. In the present study, we prospectively applied the Z0011 eligibility criteria to Chinese patients with clinically node-negative breast cancer undergoing BCT, with planned RT. The purpose of this study is the clinicopathological relevance of the Z0011 findings for Chinese patients with breast cancer, and to verify the feasibility of using the Z0011 criteria to avoid ALND after positive SLN findings.
This is a prospective single-arm study, enrolled patients meeting Z0011 inclusion criteria and providing consent to receive no additional ALND. Overall survival is the primary end point, disease-free survival and occurrence of surgical morbidities a secondary end point.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACOSOG Z0011 no further ALND arm | – | Procedure: no further ALND armpatients meeting the criteria for ACOSOG Z0011 trial inclusion：histologically confirmed invasive breast cancer;clinical T1/T2;breast conserving surgery；1 or 2 positive sentinel lymph nodes; Whole-breast RT planned; no preoperative chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- histologically confirmed invasive breast cancer patients, who meeting the critiera of Z0011 inclusion: T1 or T2 tumor,1 or 2 positive sentinel lymph nodes,breast-conserving surgery and whole-breast RT planned is enrolled.
Key inclusion criteria (1 listed)
- histologically confirmed invasive breast cancer T1 or T2 tumor 1 or 2 positive sentinel lymph nodes breast-conserving surgery whole-breast RT planned
Key exclusion criteria (1 listed)
- preoperative therapy 3 or more positive sentinel lymph nodes patients undergoing additional mastectomy due to positive surgical margins
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 |
|---|---|---|
| no further ALND armPatients meeting the Z0011 inclusion criteria to receive no additional ALND | Procedure or surgery | ACOSOG Z0011 no further ALND arm |
Primary outcome
overall survival
Time frame: 5 years
the time from surgery until death from any cause
2 secondary outcomes
disease-free survival
Time frame: 5 years
occurrence of surgical morbidities
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Results publication: PubMed 33879180Peng Y, Liu M, Li X, Tong F, Cao Y, Liu P, Zhou B, Liu H, Cheng L, Guo J, Xie F, Yang H, Wang S, Wang C, Chen Y, Wang S. Application of the ACOSOG Z0011 criteria to Chinese patients with breast cancer: a prospective study. World J Surg Oncol. 2021 Apr 20;19(1):128. doi: 10.1186/s12957-021-02242-1.
- Individual participant dataSharing planned: No
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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.
shu wang principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Sentinel Lymph Node, run by Peking University People's Hospital 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Oct 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03606616, which also lists 1 linked publication.
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 18 Oct 2022.