A Prospective Study of Preoperative Tumor-bed Boost Followed by Oncoplastic Surgery and Adjuvant Whole Breast Radiotherapy for Early Stage Breast Cancer (BIRKIN) (BIRKIN)
Breast Neoplasms
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Breast cancer, MRI guided radiotherapy, Pre-operative radiotherapy, Ultra-hypofractionation
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with invasive breast cancer; cN0 based on clinical physical examination combined with at least two imaging tests, or axillary fine-needle biopsy proved pN0; Patients who plan to receive breast-conserving surgery or breast-conserving oncoplastic surgery; No distant metastasis; The primary tumour> 5mm from the skin, without invasion of the ribs or intercostal muscles; No neoadjuvant systemic therapy; Patients who can tolerate MRI; Life expectancy ≥5 years; Organ function is fine (Hemoglobin ≥100g/L, leukocyte ≥2×109/L, neutrophil ≥1×109/L, platelet ≥80×109/L; Creatinine 1.5 mg/dl or less; Alanine aminotransferase/aspartate aminotransferase ≤2.5×UNL.); Patients are willing to cooperate to follow up; Patients should sign the informed consent; Women of childbearing age need effective contraception. Exclusion Criteria: Concurrent active connective tissue disease; Patients who had radiotherapy to the ipsilateral breast or adjacent areas before; Other malignancies, which affect pateint life expectancy (except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder neoplasms (no more than T1)); Severe comorbidities or active disease (Poorly controlled heart disease: New York Classification of Cardiac Function ≥ Grade 2, active coronary heart disease, unstable angina pectoris, arrhythmia requiring medical treatment/persistent refractory hypertension; Myocardial infarction, stroke within six months; Poorly controlled diabetes persists. Fasting blood glucose ≥ 10mmol/L, 2 hours postprandial blood glucose ≥ 13 mmol/L. Poorly controlled psychosis develops or worsens within six months; Active infection; Positive for antibodies to HIV).
Sites / Locations
- National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Experimental
preoperative tumor-bed boost
The participants receive preoperative tumor-bed boost, oncoplastic surgery and adjuvant WBRT±RNI.