Breast CancerNCT06383663
Supraclavicular Lymph Node Dissection for Ipsilateral Supraclavicular Lymph Node Metastatic Breast Cancer
A study testing Supraclavicular lymph node dissection combined with radiotherapy and radiotherapy in people with Breast Cancer and Ipsilateral Supraclavicular Lymph Node Metastasis, run by Sun Yat-sen University.
Trial summary
The purpose of this study was to compare the efficacy of surgical dissection of supraclavicular lymph nodes combined with radiotherapy versus radiotherapy alone in patients with ipsilateral supraclavicular lymph node metastasis. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Ipsilateral Supraclavicular Lymph Node Metastasis
- What is being tested?
- Supraclavicular lymph node dissection combined with radiotherapy and radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 452 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 31 Dec 2029
- Phase
- Interventional
- 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 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated primary breast cancer with supraclavicular lymph node metastasis or supraclavicular lymph node metastasis without other metastasis within 5 years after combined therapy; The diagnostic criteria refer to the diagnostic criteria for "primary breast cancer" and "Stage pN3c" in the AJCC Guidelines published on November 8, 2018;
- Supraclavicular lymph node metastasis was confirmed by pathology;
- Consent to receive biopsy of breast cancer and supraclavicular lymph node tissue;
- Patients with primary breast cancer have no history of malignant tumors and have not received chemotherapy, radiotherapy or endocrine therapy;
- Have at least one measurable target lesion according to RECIST criteria;
- ECOG score ≦ 1;
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- The level of organ function must meet the following requirements: adequate bone marrow reserve: absolute counts of neutrophils (lobed and band neutrophils) ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 9 g/dL. Liver: Bilirubin <1.5 times the upper limit of normal, alkaline phosphatase (AP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3.0 times the upper limit of normal. Renal: Creatinine clearance ≥ 45 mL/min;
- No distant metastases were found in preoperative imaging examination of whole abdominal color ultrasound, chest CT or MRI, bone scan, or PET/CT;
- normal mind, can cooperate to complete the treatment;
- Expected survival ≥36 months
- In accordance with the requirements of the Ethics Committee, there is an informed consent signed by the patient or her legal representative, or an informed consent signed by the patient and her family.
Who cannot join
- The range of metastasis exceeds the neck IV and VB region;
- En-bloc resection cannot be achieved;
- Patients with heart, lung, vascular and other diseases cannot receive antitumor therapy;
- Preoperative examination found distant metastasis;
- Pregnant, lactating or inflammatory breast cancer patients;
- Diseases associated with immune, endocrine or cardiovascular systems;
- Previous history of other tumors or combined with other tumors;
- Refusing to comply with the study protocol and refusing to sign the informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Multicenter Randomized Controlled Trial of the Prognostic Effects of Supraclavicular Lymph Node Dissection vs. No-dissection in Ipsilateral Supraclavicular Lymph Node Metastasis in Breast Cancer
The purpose of this study was to compare the efficacy of surgical dissection of supraclavicular lymph nodes combined with radiotherapy versus radiotherapy alone in patients with ipsilateral supraclavicular lymph node metastasis.
Read the detailed description
In this study, patients with ipsilateral supraclavicular lymph node positive breast cancer were selected as research subjects. Randomized controlled method was used to study the effects of surgical dissection of supraclavicular lymph node combined with radiotherapy and radiotherapy alone on progression-free survival and overall survival of breast cancer. This RCT aims to explore the best treatment method for ipsilateral supraclavicular lymph node metastasis and to provide the basis for guiding the precise treatment of supraclavicular lymph node chain.
- Being tested
- Supraclavicular lymph node dissection combined with radiotherapy, radiotherapy
- 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 dissection combined with radiotherapyProcedure or surgery
Breast cancer patients in the expreimental cohort with only ipsilateral supraclavicular lymph node metastasis were first treated with supraclavicular lymph node dissection and received standard radiotherapy after surgery.
radiotherapyRadiation
Patients in the control group received only standard radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Supraclavicular lymph node dissection combined with radiotherapy | Experimental | Breast cancer patients with ipsilateral supraclavicular lymph node metastases receive standard radiotherapy after supraclavicular lymph node dissection. Receives: Procedure: Supraclavicular lymph node dissection combined with radiotherapy |
| radiotherapy | Placebo comparator | Breast cancer patients with ipsilateral supraclavicular lymph node metastases receive only standard radiotherapy. Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
Disease-free survival
Measured: 5-year
Secondary outcomes (2)
PFS
Progression-free survival
Measured: 3-year
OS
Overall survival
Measured: 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 Sun Yat-sen UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Supraclavicular lymph node dissection combined with radiotherapy versus radiotherapy alone
- Masking
- None (open label)
- Enrolment
- 452 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Wei, Sun Yat-sen University
- Investigators
- Weidong Wei, Professor, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383663
- Sponsor's protocol ID
- 308-2019-04-01
- Status last verified
- Apr 2024
- First submitted
- 21 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Recht A, Gray R, Davidson NE, Fowble BL, Solin LJ, Cummings FJ, Falkson G, Falkson HC, Taylor SG 4th, Tormey DC. Locoregional failure 10 years after mastectomy and adjuvant chemotherapy with or without tamoxifen without irradiation: experience of the Eastern Cooperative Oncology Group. J Clin Oncol. 1999 Jun;17(6):1689-700. doi: 10.1200/JCO.1999.17.6.1689.
PubMed 10561205Chen SC, Chen MF, Hwang TL, Chao TC, Lo YF, Hsueh S, Chang JT, Leung WM. Prediction of supraclavicular lymph node metastasis in breast carcinoma. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):614-9. doi: 10.1016/s0360-3016(01)02680-3.
PubMed 11849781Chang XZ, Yin J, Sun J, Zhang XH, Cao XC. A retrospective study of different local treatments in breast cancer patients with synchronous ipsilateral supraclavicular lymph node metastasis. J Cancer Res Ther. 2013 Nov;9 Suppl:S158-61. doi: 10.4103/0973-1482.122514.
PubMed 24516053Jung J, Kim SS, Ahn SD, Lee SW, Ahn SH, Son BH, Lee JW, Choi EK. Treatment Outcome of Breast Cancer with Pathologically Proven Synchronous Ipsilateral Supraclavicular Lymph Node Metastases. J Breast Cancer. 2015 Jun;18(2):167-72. doi: 10.4048/jbc.2015.18.2.167. Epub 2015 Jun 26.
PubMed 26155293Lakatos E. Designing complex group sequential survival trials. Stat Med. 2002 Jul 30;21(14):1969-89. doi: 10.1002/sim.1193.
PubMed 12111882
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Randomized Controlled Trial of the Prognostic Effects of Supraclavicular Lymph Node Dissection vs. No-dissection in Ipsilateral Supraclavicular Lymph Node Metastasis in Breast Cancer
- ClinicalTrials.gov ID
- NCT06383663
- Acronym / sponsor ID
- 308-2019-04-01
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 452 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 25 Apr 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.
The purpose of this study was to compare the efficacy of surgical dissection of supraclavicular lymph nodes combined with radiotherapy versus radiotherapy alone in patients with ipsilateral supraclavicular lymph node metastasis.
Detailed description
In this study, patients with ipsilateral supraclavicular lymph node positive breast cancer were selected as research subjects. Randomized controlled method was used to study the effects of surgical dissection of supraclavicular lymph node combined with radiotherapy and radiotherapy alone on progression-free survival and overall survival of breast cancer. This RCT aims to explore the best treatment method for ipsilateral supraclavicular lymph node metastasis and to provide the basis for guiding the precise treatment of supraclavicular lymph node chain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Supraclavicular lymph node dissection combined with radiotherapy versus radiotherapy alone
| Arm | Type | Receives |
|---|---|---|
| Supraclavicular lymph node dissection combined with radiotherapy | Experimental | Procedure: Supraclavicular lymph node dissection combined with radiotherapyBreast cancer patients with ipsilateral supraclavicular lymph node metastases receive standard radiotherapy after supraclavicular lymph node dissection. |
| radiotherapy | Placebo comparator | Radiation: radiotherapyBreast cancer patients with ipsilateral supraclavicular lymph node metastases receive only standard radiotherapy. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Previously untreated primary breast cancer with supraclavicular lymph node metastasis or supraclavicular lymph node metastasis without other metastasis within 5 years after combined therapy; The diagnostic criteria refer to the diagnostic criteria for "primary breast cancer" and "Stage pN3c" in the AJCC Guidelines published on November 8, 2018;
- Supraclavicular lymph node metastasis was confirmed by pathology;
- Consent to receive biopsy of breast cancer and supraclavicular lymph node tissue;
- Patients with primary breast cancer have no history of malignant tumors and have not received chemotherapy, radiotherapy or endocrine therapy;
- Have at least one measurable target lesion according to RECIST criteria;
Key exclusion criteria (8 listed)
- The range of metastasis exceeds the neck IV and VB region;
- En-bloc resection cannot be achieved;
- Patients with heart, lung, vascular and other diseases cannot receive antitumor therapy;
- Preoperative examination found distant metastasis;
- Pregnant, lactating or inflammatory breast cancer patients;
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 dissection combined with radiotherapyBreast cancer patients in the expreimental cohort with only ipsilateral supraclavicular lymph node metastasis were first treated with supraclavicular lymph node dissection and received standard radiotherapy after surgery. | Procedure or surgery | Supraclavicular lymph node dissection combined with radiotherapy |
| radiotherapyPatients in the control group received only standard radiation therapy. | Radiation | radiotherapy |
Primary outcome
DFS
Time frame: 5-year
Disease-free survival
2 secondary outcomes
PFS
Time frame: 3-year
OS
Time frame: 5-year
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 30 Apr 2024.
- Background: PubMed 10561205Recht A, Gray R, Davidson NE, Fowble BL, Solin LJ, Cummings FJ, Falkson G, Falkson HC, Taylor SG 4th, Tormey DC. Locoregional failure 10 years after mastectomy and adjuvant chemotherapy with or without tamoxifen without irradiation: experience of the Eastern Cooperative Oncology Group. J Clin Oncol. 1999 Jun;17(6):1689-700. doi: 10.1200/JCO.1999.17.6.1689.
- Background: PubMed 11849781Chen SC, Chen MF, Hwang TL, Chao TC, Lo YF, Hsueh S, Chang JT, Leung WM. Prediction of supraclavicular lymph node metastasis in breast carcinoma. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):614-9. doi: 10.1016/s0360-3016(01)02680-3.
- Background: PubMed 24516053Chang XZ, Yin J, Sun J, Zhang XH, Cao XC. A retrospective study of different local treatments in breast cancer patients with synchronous ipsilateral supraclavicular lymph node metastasis. J Cancer Res Ther. 2013 Nov;9 Suppl:S158-61. doi: 10.4103/0973-1482.122514.
- Background: PubMed 26155293Jung J, Kim SS, Ahn SD, Lee SW, Ahn SH, Son BH, Lee JW, Choi EK. Treatment Outcome of Breast Cancer with Pathologically Proven Synchronous Ipsilateral Supraclavicular Lymph Node Metastases. J Breast Cancer. 2015 Jun;18(2):167-72. doi: 10.4048/jbc.2015.18.2.167. Epub 2015 Jun 26.
- Background: PubMed 12111882Lakatos E. Designing complex group sequential survival trials. Stat Med. 2002 Jul 30;21(14):1969-89. doi: 10.1002/sim.1193.
- 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.
Weidong Wei, Professor principal investigator
Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A study testing Supraclavicular lymph node dissection combined with radiotherapy and radiotherapy in people with Breast Cancer and Ipsilateral Supraclavicular Lymph Node Metastasis, run by Sun Yat-sen University.
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 11 inclusion and 8 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: opening soon, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Weidong Wei, Professor (+8613822278328, weiwd@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: 5-year). 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 NCT06383663, which also lists 5 linked publications.
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 30 Apr 2024.