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Trial Title:
Supraclavicular Lymph Node Dissection for Ipsilateral Supraclavicular Lymph Node Metastatic Breast Cancer
NCT ID:
NCT06383663
Condition:
Breast Cancer
Ipsilateral Supraclavicular Lymph Node Metastasis
Conditions: Official terms:
Breast Neoplasms
Neoplasm Metastasis
Lymphatic Metastasis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Supraclavicular lymph node dissection combined with radiotherapy versus radiotherapy
alone
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Supraclavicular lymph node dissection combined with radiotherapy
Description:
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.
Arm group label:
Supraclavicular lymph node dissection combined with radiotherapy
Intervention type:
Radiation
Intervention name:
radiotherapy
Description:
Patients in the control group received only standard radiation therapy.
Arm group label:
radiotherapy
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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;
2. Supraclavicular lymph node metastasis was confirmed by pathology;
3. Consent to receive biopsy of breast cancer and supraclavicular lymph node tissue;
4. Patients with primary breast cancer have no history of malignant tumors and have not
received chemotherapy, radiotherapy or endocrine therapy;
5. Have at least one measurable target lesion according to RECIST criteria;
6. ECOG score ≦ 1;
7. 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;
8. No distant metastases were found in preoperative imaging examination of whole
abdominal color ultrasound, chest CT or MRI, bone scan, or PET/CT;
9. normal mind, can cooperate to complete the treatment;
10. Expected survival ≥36 months
11. 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.
Exclusion Criteria:
1. The range of metastasis exceeds the neck IV and VB region;
2. En-bloc resection cannot be achieved;
3. Patients with heart, lung, vascular and other diseases cannot receive antitumor
therapy;
4. Preoperative examination found distant metastasis;
5. Pregnant, lactating or inflammatory breast cancer patients;
6. Diseases associated with immune, endocrine or cardiovascular systems;
7. Previous history of other tumors or combined with other tumors;
8. Refusing to comply with the study protocol and refusing to sign the informed consent
Gender:
Female
Minimum age:
35 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
May 1, 2024
Completion date:
December 31, 2029
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06383663
