Locally Advanced Breast CancerNCT06605521
To Evaluate the Efficacy and Safety of Ipsilateral Supraclavicular Lymph Node Dissection for Breast Cancer Patients
An observational study of Locally Advanced Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
For newly diagnosed ISLNM breast cancer, on the basis of effective treatment of the new auxiliary system, the optimal local treatment of the supraclavicular region remains controversial. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Locally Advanced Breast Cancer
- What is being tested?
- Subclavian lymph node dissection+radiotherapy and Simple clavicular region radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 4 Apr 2023to 4 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- Women only
- Adult, Older adult
Study population: cT1-4N3M0 breast cancer
Who may be able to join
- Female patients aged ≤ 80 years old.
- ECOG score 0-1 points;
- Breast cancer meets the following criteria: histologically diagnosed as invasive breast cancer, known ER, PR, HER2, KI67 status, pathologically diagnosed as ipsilateral supraclavicular lymph node metastasis (both cytology and histopathology);
- Estimated patient survival time exceeding three months;
- No obvious contraindications for surgery or radiotherapy;
- The researcher judged that they were able to comply with the research protocol.
- Those who participate in other clinical trials (including intervention or non intervention studies) at the same time and are judged by the researchers not to affect the research protocol can be enrolled normally.
- Voluntarily participate in this study and sign an informed consent form.
Who cannot join
- Stage IV (metastatic) breast cancer;
- Bilateral breast cancer;
- Received radiotherapy and surgical treatment (excluding local puncture) for ipsilateral supraclavicular metastatic lymph nodes before enrollment;
- History of breast cancer or other malignant tumors, but excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma;
- Individuals with severe primary diseases such as cardiovascular, cerebrovascular, liver, and kidney that are difficult to tolerate surgery or radiation therapy;
- Having a history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;
- Suffering from severe comorbidities or other comorbidities that may interfere with the planned treatment, or any other circumstances in which the researcher deems the patient unsuitable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Minhao Lv, 0371-65587405, zlyylvminhao2789@zzu.edu.cn
About this study
Official title: To Evaluate the Efficacy and Safety of Ipsilateral Supraclavicular Lymph Node Dissection for Breast Cancer Patients: A Prospective, Multicenter, Non-interventionist Real World Study
For newly diagnosed ISLNM breast cancer, on the basis of effective treatment of the new auxiliary system, the optimal local treatment of the supraclavicular region remains controversial. Although guidelines such as NCCN recommend simple clavicular radiation therapy, there are studies suggesting that supraclavicular lymph node dissection can improve prognosis, and many hospitals in China are still accustomed to performing supraclavicular lymph node dissection. Therefore, ipsilateral supraclavicular lymph node dissection is the first time to diagnose ipsilateral supraclavicular lymph node metastasis of breast cancer. The effectiveness and safety of (stage IIIc) treatment still require prospective research to confirm.This project is a prospective, multicenter, non-interference real world study. In the real world study, the investigators evaluated the efficacy and safety of ipsilateral supraclavicular lymph node dissection in the treatment of initially diagnosed ipsilateral supraclavicular lymph node metastasis breast cancer patients.
Read the detailed description
For newly diagnosed ISLNM breast cancer, on the basis of effective treatment of the new auxiliary system, the optimal local treatment of the supraclavicular region remains controversial. Although guidelines such as NCCN recommend simple clavicular radiation therapy, there are studies suggesting that supraclavicular lymph node dissection can improve prognosis, and many hospitals in China are still accustomed to performing supraclavicular lymph node dissection. Therefore, ipsilateral supraclavicular lymph node dissection is the first time to diagnose ipsilateral supraclavicular lymph node metastasis of breast cancer. The effectiveness and safety of (stage IIIc) treatment still require prospective research to confirm.This project is a prospective, multicenter, non-interference real world study. In the real world study, the investigators evaluated the efficacy and safety of ipsilateral supraclavicular lymph node dissection in the treatment of initially diagnosed ipsilateral supraclavicular lymph node metastasis breast cancer patients.
The main endpoint of the study was recurrence free survival on the ipsilateral clavicle. The secondary study endpoint is disease-free survival; Ipsilateral supraclavicular relapse-free survival; Rregional lymph node relapse-free survival; Overall survival; Security; The incidence of upper limb lymphedema; Patient's quality of life.
- Conditions
- Locally Advanced Breast Cancer
- Being tested
- Subclavian lymph node dissection+radiotherapy, Simple clavicular region radiotherapy
- Keywords
- Supraclavicular lymph node dissection, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subclavian lymph node dissection+radiotherapyProcedure or surgery
Also called experimental group
The patient grouping is determined jointly by the researchers and participants, and patients in Group A are selected for supraclavicular lymph node dissection and radiotherapy.
Simple clavicular region radiotherapyProcedure or surgery
Also called control group
If the patient chooses Group B treatment plan, they will receive simple clavicle area radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Subclavian lymph node dissection+radiotherapy group | Subclavian lymph node dissection+radiotherapy Receives: Procedure: Subclavian lymph node dissection+radiotherapy | |
| Simple clavicular region radiotherapy group | Simple clavicular region radiotherapy Receives: Procedure: Simple clavicular region radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraclavicular recurrence free survival in group A patients
The time from surgery to ipsilateral supraclavicular fossa recurrence or last follow-up.
Measured: 5th year after surgery
Secondary outcomes (7)
Disease-Free Survival
The time from surgery to the occurrence of recurrence, metastasis, or last follow-up.
Measured: 5th year after surgery
Intraclavicular recurrence free survival in group B patients
The time from surgery to ipsilateral supraclavicular fossa recurrence or last follow-up
Measured: 5th year after surgery
Regional lymph node recurrence free survival in group A/B patients
The time from surgery to the occurrence of regional lymph node recurrence, metastasis, or last follow-up
Measured: 5th year after surgery
Overall survival of patients in Group A/B
The time from surgery to patient death or last follow-up
Measured: 5th year after surgery
Number of adverse events
Complications related to surgery and radiotherapy
Measured: through study completion, an average of 2 year
The incidence of upper limb lymphedema in group A/B patients at 2 years after surgery
Measure the circumference using the circumference method, with the styloid process of the ulna as the starting point, spaced 10cm apart and measured up to 40cm.
Measured: 2th year after surgery
Patient's quality of life
Evaluate using the EORTC-QLQ-C30 V3 （European Organization of Research and treatment of Cancer-Questionnaire of Life Quality-C30 Version 3）scale.EORTC-QLQ-C30 V3 is the core scale of the quality of life measurement system developed by the European Organization for Research and Treatment of Cancer (EORTC) for cancer patients. The original scores of each item in the scale need to be converted into standardized scores ranging from 0 to 100 using linear formulas. The higher the scores of each functional dimension, the better the functional status; The higher the score of the symptom scale and individual items, the more obvious the symptoms and the poorer the quality of life.
Measured: 2th year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start4 Apr 2023
- Primary completion4 Apr 2027 (estimated)
- Study completion4 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- xiuchun Chen, Study chair, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605521
- Sponsor's protocol ID
- 2023-122
- Status last verified
- Feb 2024
- First submitted
- 6 May 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of Ipsilateral Supraclavicular Lymph Node Dissection for Breast Cancer Patients: A Prospective, Multicenter, Non-interventionist Real World Study
- ClinicalTrials.gov ID
- NCT06605521
- Acronym / sponsor ID
- 2023-122
- Conditions
- Locally Advanced Breast Cancer
- Keywords
- Supraclavicular lymph node dissection, breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 4 Apr 2027 (estimated)
- Study completion
- 4 Apr 2027 (estimated)
- First posted
- 20 Sep 2024 (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.
For newly diagnosed ISLNM breast cancer, on the basis of effective treatment of the new auxiliary system, the optimal local treatment of the supraclavicular region remains controversial. Although guidelines such as NCCN recommend simple clavicular radiation therapy, there are studies suggesting that supraclavicular lymph node dissection can improve prognosis, and many hospitals in China are still accustomed to performing supraclavicular lymph node dissection. Therefore, ipsilateral supraclavicular lymph node dissection is the first time to diagnose ipsilateral supraclavicular lymph node metastasis of breast cancer. The effectiveness and safety of (stage IIIc) treatment still require prospective research to confirm.This project is a prospective, multicenter, non-interference real world study. In the real world study, the investigators evaluated the efficacy and safety of ipsilateral supraclavicular lymph node dissection in the treatment of initially diagnosed ipsilateral supraclavicular lymph node metastasis breast cancer patients.
Detailed description
For newly diagnosed ISLNM breast cancer, on the basis of effective treatment of the new auxiliary system, the optimal local treatment of the supraclavicular region remains controversial. Although guidelines such as NCCN recommend simple clavicular radiation therapy, there are studies suggesting that supraclavicular lymph node dissection can improve prognosis, and many hospitals in China are still accustomed to performing supraclavicular lymph node dissection. Therefore, ipsilateral supraclavicular lymph node dissection is the first time to diagnose ipsilateral supraclavicular lymph node metastasis of breast cancer. The effectiveness and safety of (stage IIIc) treatment still require prospective research to confirm.This project is a prospective, multicenter, non-interference real world study. In the real world study, the investigators evaluated the efficacy and safety of ipsilateral supraclavicular lymph node dissection in the treatment of initially diagnosed ipsilateral supraclavicular lymph node metastasis breast cancer patients.
The main endpoint of the study was recurrence free survival on the ipsilateral clavicle. The secondary study endpoint is disease-free survival; Ipsilateral supraclavicular relapse-free survival; Rregional lymph node relapse-free survival; Overall survival; Security; The incidence of upper limb lymphedema; Patient's quality of life.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subclavian lymph node dissection+radiotherapy group | – | Procedure: Subclavian lymph node dissection+radiotherapySubclavian lymph node dissection+radiotherapy |
| Simple clavicular region radiotherapy group | – | Procedure: Simple clavicular region radiotherapySimple clavicular region radiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- cT1-4N3M0 breast cancer
Key inclusion criteria (8 listed)
- Female patients aged ≤ 80 years old.
- ECOG score 0-1 points;
- Breast cancer meets the following criteria: histologically diagnosed as invasive breast cancer, known ER, PR, HER2, KI67 status, pathologically diagnosed as ipsilateral supraclavicular lymph node metastasis (both cytology and histopathology);
- Estimated patient survival time exceeding three months;
- No obvious contraindications for surgery or radiotherapy;
Key exclusion criteria (7 listed)
- Stage IV (metastatic) breast cancer;
- Bilateral breast cancer;
- Received radiotherapy and surgical treatment (excluding local puncture) for ipsilateral supraclavicular metastatic lymph nodes before enrollment;
- History of breast cancer or other malignant tumors, but excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma;
- Individuals with severe primary diseases such as cardiovascular, cerebrovascular, liver, and kidney that are difficult to tolerate surgery or radiation therapy;
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 |
|---|---|---|
| Subclavian lymph node dissection+radiotherapyAlso: experimental groupThe patient grouping is determined jointly by the researchers and participants, and patients in Group A are selected for supraclavicular lymph node dissection and radiotherapy. | Procedure or surgery | Subclavian lymph node dissection+radiotherapy group |
| Simple clavicular region radiotherapyAlso: control groupIf the patient chooses Group B treatment plan, they will receive simple clavicle area radiotherapy. | Procedure or surgery | Simple clavicular region radiotherapy group |
Primary outcome
Intraclavicular recurrence free survival in group A patients
Time frame: 5th year after surgery
The time from surgery to ipsilateral supraclavicular fossa recurrence or last follow-up.
7 secondary outcomes
Disease-Free Survival
Time frame: 5th year after surgery
Intraclavicular recurrence free survival in group B patients
Time frame: 5th year after surgery
Regional lymph node recurrence free survival in group A/B patients
Time frame: 5th year after surgery
Overall survival of patients in Group A/B
Time frame: 5th year after surgery
Number of adverse events
Time frame: through study completion, an average of 2 year
The incidence of upper limb lymphedema in group A/B patients at 2 years after surgery
Time frame: 2th year after surgery
Patient's quality of life
Time frame: 2th year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
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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.
xiuchun Chen study chair
Henan Cancer 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 Locally Advanced Breast Cancer, run by Henan Cancer 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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiuchun Chen (0371-65587405, zlyychenxiuchun3921@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraclavicular recurrence free survival in group A patients (time frame: 5th year after surgery). 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 20 Sep 2024.