Breast Cancer Stage IIINCT03716245
Clinical Significance of Supraclavicular Lymph Node Dissection for Breast Cancer
A study testing supraclavicular lymph node dissection and supraclavicular area radiotherapy in people with Breast Cancer Stage III, run by Xinhong Wu, PhD at 1 site in China.
Trial summary
Breast cancer patients with ipsilateral supraclavicular lymph node metastasis are defined as Ⅲc stage (N3) according to the newly published 8th AJCC TNM staging system. No concret guide line was supported to such patients. Read more about this study
- Who is it for?
- Ages Up to 75 years, women only
- Conditions the study is for
- Breast Cancer Stage III
- What is being tested?
- supraclavicular lymph node dissection and supraclavicular area radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2019to 20 Jan 2024
- Phase
- Interventional
- 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 Up to 75 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ability to understand the study procedures and contents, and willingness to voluntarily sign the written informed consent form;
- Age≤75 years old, female;
- Histologically confirmed breast cancer;
- Histologically or cytologically confirmed ipsilateral supraclavicular lymph node metastasis；
- cT0-T3；
- low and moderate risk for anesthesia
Who cannot join
- Absolute and relative contraindication for surgery or radiation；
- existing distant metastasis before surgery；
- non-invasive breast cancer；
- with contralateral breast cancer；
- Previous history of breast cancer or other malignancies；
- ECOG≥2；
Show all 9Show fewer
- inflammatory breast cancer；
- pregnancy；
- any serious complications which caused patients not suitable to participate this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomised, Open-label Prospective Clinical Trial to Evaluate the Clinical Significance of Supraclavicular Lymph Node Dissection for Breast Cancer Patients With Ipsilateral Supraclavicular Lymph Node Metastasis
Breast cancer patients with ipsilateral supraclavicular lymph node metastasis are defined as Ⅲc stage (N3) according to the newly published 8th AJCC TNM staging system. No concret guide line was supported to such patients. It is still pending whether to exert supraclavicular lymph node dissection to breast cancer patients with ipsilateral supraclavicular lymph node metastasis.
To evaluate the clinical significance and complication of supraclavicular lymph node dissection for breast cancer patients with ipsilateral supraclavicular lymph node metastasis, the investigators randomize patients into two groups, one group is supraclavicular lymph node dissection with radiotherapy group, the other group is radiotherapy group.
Read the detailed description
Breast cancer is the most common cancer and the leading cause of deaths from cancer in women worldwide. Breast cancer patients with ipsilateral supraclavicular lymph node metastasis are defined as Ⅲc stage (N3) according to the newly published 8th AJCC TNM staging system. Clinical outcomes are similar for patients with ipsilateral supraclavicular lymph node metastases at first presentation and for patients with recurrent ipsilateral supraclavicular lymph node metastases. The survival rate was lower in patients with ipsilateral supraclavicular lymph node metastases than in patients with lower axillary or subclavian nodal involvement. No concrete guide line was supported to such patients. It is still pending whether to exert supraclavicular lymph node dissection to breast cancer patients with ipsilateral supraclavicular lymph node metastasis. Patients with ipsilateral supraclavicular lymph node metastases who were treated with surgery or radiotherapy and achieved good neck control were reported to achieve better survival than those for whom surgical treatment or irradiation did not result in good local control.
Patients with ipsilateral supraclavicular lymph node metastases should be offered a combined modality approach, including systemic therapy, surgery, and radiotherapy. Furthermore, local treatment, usually including axillary and supraclavicular lymph node, either by surgical clearance or by radical radiotherapy, can prevent the tumor cells from drainage, might be play a more important role. However, the role of surgical removal of the supraclavicular nodes is uncertain compared with radical radiotherapy. To our knowledge, the available literature comparing these two local treatments of ipsilateral supraclavicular lymph node metastases is scarce. Furthermore, the studies comparing the outcome of dissection of supraclavicular lymph node combined with local radiotherapy and radiotherapy of supraclavicular lymph node is also rare. All the related reports up to date have mixed them up.
To evaluate the clinical significance and complication of supraclavicular lymph node dissection for breast cancer patients with ipsilateral supraclavicular lymph node metastasis, we randomize patients into two groups, one group is supraclavicular lymph node dissection with radiotherapy group, the other group is radiotherapy group.
Therefore, in addition to investigating the role of surgical removal of the supraclavicular nodes in Chinese patients, we also try to reveal the potential difference between these two treatments, hoping to bring more insight into clinical practice.
- Conditions
- Breast Cancer Stage III
- Being tested
- supraclavicular lymph node dissection, supraclavicular area radiotherapy
- Keywords
- breast cancer, supraclavicular lymph node, dissection, radiotherpy, prognosis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supraclavicular lymph node dissectionProcedure or surgery
people with supraclavicular lymph node metastasis before surgery should receive dissection of supraclavicular lymph node and the supraclavicular lymph node metastasis should be confirmed either by core needle biopsy or fine needle aspiration biopsy
supraclavicular area radiotherapyRadiation
people with supraclavicular lymph node metastasis before surgery should receive radiotherapy of supraclavicular area and the supraclavicular lymph node metastasis should be confirmed either by core needle biopsy or fine needle aspiration biopsy
| Study group | Role | What they receive |
|---|---|---|
| supraclavicular lymph node dissection and raidiotherapy | Experimental | breast cancer patients with supraclavicular lymph node metastasis receive supraclavicular lymph node dissection and supraclavicular area radiotherapy Receives: Procedure: supraclavicular lymph node dissection |
| supraclavicular area radiotherapy | Active comparator | breast cancer patients with supraclavicular lymph node metastasis receive supraclavicular area radiotherapy Receives: Radiation: supraclavicular area radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Disease free survival for 3 years and 5 years, which means the rate of patients without local recurrence and distant metastasis in the whole patients at the same group will be calculated with Kaplan Meier survival curves.
Measured: 3-5 years
Secondary outcomes (4)
Occurring rate of complications
Occurring rate of complications including the occurring rate of infection, hemorrhage, limb lymphedema, time in hospital, brachial plexopahy, radiation induced lung injury in each group were recorded in patients' medical record.
Measured: 3-5 years
Overall survival
Overall survival for 3 years and 5 years, which means the rate of patients alive in the whole patients at the same group will be calculated with kaplan meier survival curves.
Measured: 3-5 years
Life quality score
Life quality score was evaluated by European Organization of Research and treatment of Cancer-Questionnaire of Life Quality-C30 Version 3 (EORTC-QLQ-C30 V3), which conduct a series of questions about the patients' physical condition, activity of daily life, adverse reaction and mood condition. The range in the questionnaire for the score is from 1 to 4, in which 1 stands for having no discomfort and 4 stands for having great discomfort.
Measured: 3-5 years
Recurrence free survival
Recurrence free survival for 3 years and 5 years, which means the rate of patients without local recurrence in the whole patients at the same group will be calculated with Kaplan Meier survival curves.
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start27 Feb 2019
- Primary completion20 Jan 2024
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IIIStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinhong Wu, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xinhong Wu, PhD, Hubei Cancer Hospital
- Investigators
- Xinhong Wu, Doctor, Principal investigator, Hubei Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716245
- Sponsor's protocol ID
- SCLND0919
- Status last verified
- Jan 2024
- First submitted
- 14 Oct 2018
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomised, Open-label Prospective Clinical Trial to Evaluate the Clinical Significance of Supraclavicular Lymph Node Dissection for Breast Cancer Patients With Ipsilateral Supraclavicular Lymph Node Metastasis
- ClinicalTrials.gov ID
- NCT03716245
- Acronym / sponsor ID
- SCLND0919
- Conditions
- Breast Cancer Stage III
- Keywords
- breast cancer, supraclavicular lymph node, dissection, radiotherpy, prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Xinhong Wu, PhDUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 23 Oct 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.
Breast cancer patients with ipsilateral supraclavicular lymph node metastasis are defined as Ⅲc stage (N3) according to the newly published 8th AJCC TNM staging system. No concret guide line was supported to such patients. It is still pending whether to exert supraclavicular lymph node dissection to breast cancer patients with ipsilateral supraclavicular lymph node metastasis.
To evaluate the clinical significance and complication of supraclavicular lymph node dissection for breast cancer patients with ipsilateral supraclavicular lymph node metastasis, the investigators randomize patients into two groups, one group is supraclavicular lymph node dissection with radiotherapy group, the other group is radiotherapy group.
Detailed description
Breast cancer is the most common cancer and the leading cause of deaths from cancer in women worldwide. Breast cancer patients with ipsilateral supraclavicular lymph node metastasis are defined as Ⅲc stage (N3) according to the newly published 8th AJCC TNM staging system. Clinical outcomes are similar for patients with ipsilateral supraclavicular lymph node metastases at first presentation and for patients with recurrent ipsilateral supraclavicular lymph node metastases. The survival rate was lower in patients with ipsilateral supraclavicular lymph node metastases than in patients with lower axillary or subclavian nodal involvement. No concrete guide line was supported to such patients. It is still pending whether to exert supraclavicular lymph node dissection to breast cancer patients with ipsilateral supraclavicular lymph node metastasis. Patients with ipsilateral supraclavicular lymph node metastases who were treated with surgery or radiotherapy and achieved good neck control were reported to achieve better survival than those for whom surgical treatment or irradiation did not result in good local control.
Patients with ipsilateral supraclavicular lymph node metastases should be offered a combined modality approach, including systemic therapy, surgery, and radiotherapy. Furthermore, local treatment, usually including axillary and supraclavicular lymph node, either by surgical clearance or by radical radiotherapy, can prevent the tumor cells from drainage, might be play a more important role. However, the role of surgical removal of the supraclavicular nodes is uncertain compared with radical radiotherapy. To our knowledge, the available literature comparing these two local treatments of ipsilateral supraclavicular lymph node metastases is scarce. Furthermore, the studies comparing the outcome of dissection of supraclavicular lymph node combined with local radiotherapy and radiotherapy of supraclavicular lymph node is also rare. All the related reports up to date have mixed them up.
To evaluate the clinical significance and complication of supraclavicular lymph node dissection for breast cancer patients with ipsilateral supraclavicular lymph node metastasis, we randomize patients into two groups, one group is supraclavicular lymph node dissection with radiotherapy group, the other group is radiotherapy group.
Therefore, in addition to investigating the role of surgical removal of the supraclavicular nodes in Chinese patients, we also try to reveal the potential difference between these two treatments, hoping to bring more insight into clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supraclavicular lymph node dissection and raidiotherapy | Experimental | Procedure: supraclavicular lymph node dissectionbreast cancer patients with supraclavicular lymph node metastasis receive supraclavicular lymph node dissection and supraclavicular area radiotherapy |
| supraclavicular area radiotherapy | Active comparator | Radiation: supraclavicular area radiotherapybreast cancer patients with supraclavicular lymph node metastasis receive supraclavicular area radiotherapy |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to understand the study procedures and contents, and willingness to voluntarily sign the written informed consent form;
- Age≤75 years old, female;
- Histologically confirmed breast cancer;
- Histologically or cytologically confirmed ipsilateral supraclavicular lymph node metastasis；
- cT0-T3；
Key exclusion criteria (9 listed)
- Absolute and relative contraindication for surgery or radiation；
- existing distant metastasis before surgery；
- non-invasive breast cancer；
- with contralateral breast cancer；
- Previous history of breast cancer or other malignancies；
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 |
|---|---|---|
| supraclavicular lymph node dissectionpeople with supraclavicular lymph node metastasis before surgery should receive dissection of supraclavicular lymph node and the supraclavicular lymph node metastasis should be confirmed either by core needle biopsy or fine needle aspiration biopsy | Procedure or surgery | supraclavicular lymph node dissection and raidiotherapy |
| supraclavicular area radiotherapypeople with supraclavicular lymph node metastasis before surgery should receive radiotherapy of supraclavicular area and the supraclavicular lymph node metastasis should be confirmed either by core needle biopsy or fine needle aspiration biopsy | Radiation | supraclavicular area radiotherapy |
Primary outcome
Disease free survival
Time frame: 3-5 years
Disease free survival for 3 years and 5 years, which means the rate of patients without local recurrence and distant metastasis in the whole patients at the same group will be calculated with Kaplan Meier survival curves.
4 secondary outcomes
Occurring rate of complications
Time frame: 3-5 years
Overall survival
Time frame: 3-5 years
Life quality score
Time frame: 3-5 years
Recurrence free survival
Time frame: 3-5 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 23 Jan 2024.
- Individual participant dataSharing planned: No. Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
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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.
Xinhong Wu, Doctor principal investigator
Hubei Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supraclavicular lymph node dissection and supraclavicular area radiotherapy in people with Breast Cancer Stage III, run by Xinhong Wu, PhD 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 6 inclusion and 9 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 23 Jan 2024. 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?
Disease free survival (time frame: 3-5 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 23 Jan 2024.