Breast cancer
Conditions
Interventions
Control group:Without internal mammry irradiation
Experimental group:Internal mammry irradiation
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Signing the informed consent form; 2) Age 18-70, female; 3) Histologically confirmed primary breast cancer located in the lateral quadrant with axillary lymph node positivity; 4) Clinical stage at first diagnosis: cT1-4N+M0 (AJCC/UICC Breast Cancer Staging (8th Edition)); 5) Patients who have a ypT0-2N1-2M0 staging after neoadjuvant treatment; 6) Patients who have undergone breast-conserving or mastectomy (with more than 10 axillary lymph node dissections) and negative margins; 7) Based on the images before and after systemic treatment, there is no supraclavicular or internal mammary lymph node metastasis; 8) No distant metastasis; 9) Able to complete radiotherapy and chemotherapy as per standard protocols; 10) If indicated, expected to receive anti-HER2 (human epidermal growth factor receptor 2) therapy for 1 year and endocrine therapy for 5 years; 11) Adequate organ and bone marrow function, defined by meeting the following criteria: (1) Hematological test results meet the following standards: a) Hemoglobin level (HB) >=90g/L (without transfusion within 28 days); b) Absolute neutrophil count (ANC) >=1.5×10^9/L; c) Platelet count (PLT) >=80×10^9/L; d) White blood cell count (WBC) >=3.5×10^9/L; (2) Biochemical tests must meet the following criteria: a) Serum total bilirubin (TBIL) =60ml/min (Cockcroft-Gault formula); (3) Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >=lower limit of normal (50%); (4) Adequate coagulation function, defined as an international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN;
Exclusion criteria
Exclusion criteria: 1) Bilateral breast cancer; 2) Internal mammary lymph node metastasis at the initial diagnosis; 3) Axillary lymph node positivity at the initial diagnosis without neoadjuvant chemotherapy; 4) Incomplete R0 resection during surgery; 5) History of chest wall or supraclavicular radiotherapy; 6) Coexisting or previous second primary malignancy, except for skin cancer (excluding malignant melanoma) and papillary thyroid carcinoma; 7) Left ventricular ejection fraction (LVEF) <50% in patients receiving anti-HER2 (human epidermal growth factor receptor 2) therapy. 8) Unwilling to sign an informed consent form; 9) Presence of any one of the following comorbidities: (1) Uncontrolled angina and heart failure with a history of hospitalization within the past 3 months; (2) History of myocardial infarction within the past 6 months; (3) Acute bacterial or fungal infection requiring antibiotic treatment present; (4) Chronic obstructive pulmonary disease exacerbation or other lung diseases requiring hospitalization; (5) Substance abuse such as drug addiction, long-term alcoholism, or AIDS disease or virus carrier status; (6) Uncontrollable seizures or loss of insight due to mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Internal mammary lymph nodes local control rate;Quality of life quality; | — |
Countries
China
Contacts
Public ContactLi Duojie
The First Affiliated Hospital of Bengbu Medical University
Outcome results
None listed