N3c breast cancer
Conditions
Interventions
2:supraclavicular radiotherapy
1:Supraclavicular lymph nodes dissection plus supraclavicular radiotherapy
Sponsors
Breast Disease Center, Southwest Hospital, Third Military Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) female patients aged 18-70 years. 2) invasive breast cancer patients confirmed by core needle puncture. 3) invasive breast cancer patients with supraclavicular lymph node metastasis confirmed by fine needle puncture. 4) have not received any anti-tumor treatment, including chemotherapy, radiotherapy, targeted therapy and biological therapy. 5) ECOG score: 0-1. 6) the expected survival time is no less than 12 weeks. 7) according to RECIST 1.1, at least one measurable lesion was present. 8) the functional level of the main organs must meet the following requirements (no blood transfusion within 2 weeks before screening, and no drugs for raising white blood cells or platelets) : (1) routine blood Neutrophil (ANC) 1.5 109/L; Platelet count (PLT) 90 109/L; Hemoglobin (Hb) 90g/L; (2) blood biochemical Total bilirubin (TBIL) 1.5 ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2 ULN; Blood urea nitrogen (BUN) and creatinine (Cr) 1.5 ULN; (3) heart ultrasound Left ventricular ejection fraction (LVEF) 50%; (4) 12-leads ecg QT interval (QTcF) <470msec corrected by Fridericia method. 9) patients who volunteers to participate in this study and are willing to accept both surgical methods and randomly assigned to sign the informed consent. They have good compliance and were willing to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1) patients with metastatic breast cancer or bilateral breast cancer. 2) inflammatory breast cancer patients. 3) those who received radiotherapy, chemotherapy, surgical treatment (excluding local puncture) or molecular targeted therapy within 4 weeks before enrollment; 4) previous experience of other malignant tumors. 5) a history of immunodeficiency, including HIV test positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. 6) has suffered from any heart disease, including: 1) an arrhythmia requiring medical treatment or of clinical significance;2) myocardial infarction;3) heart failure;4) any other heart disease determined by the investigator as not suitable for the study. 7) have a clear history of neurological or mental disorders, including epilepsy or dementia. 8) female patients during pregnancy or lactation, female patients with fertility and positive results of baseline pregnancy test, or patients of reproductive age who are unwilling to take effective contraceptive measures during the whole trial period. 9) the patient has other serious concomitant diseases. 10) the investigator considers that the patient is not suitable for any other conditions in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactJun Jiang
Breast Disease Center, Southwest Hospital, Third Military Medical University
Outcome results
None listed