Breast Cancer, Ipsilateral Supraclavicular Lymph Node Metastasis
Conditions
Brief 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.
Interventions
PROCEDURESupraclavicular lymph node dissection combined with radiotherapy
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.
RADIATIONradiotherapy
Patients in the control group received only standard radiation therapy.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Supraclavicular lymph node dissection combined with radiotherapy versus radiotherapy alone
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DFS | 5-year | Disease-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 3-year | Progression-free survival |
| OS | 5-year | Overall survival |
Other
| Measure | Time frame | Description |
|---|---|---|
| pCR rate | 1-year | Pathological complete response rate |
Contacts
Primary ContactWeidong Wei, Professor
Outcome results
None listed