A Prospective Study of Preoperative Tumor-bed Boost Followed by Oncoplastic Surgery and Adjuvant Whole Breast Radiotherapy for Early Stage Breast Cancer (BIRKIN)
Recruiting · NCT05603078 · Interventional (participants receive a specific treatment) · Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study explores the feasibility of preoperative single-dose tumor-bed boost followed by oncoplastic breast-conserving surgery and ultra-hypofractionated postoperative radiotherapy in patients with early stage breast cancer. Patients less than 55 years old, who are diagnosed with breast cancer and are eligible to recieve breast-conserving surgery are enrolled. Patients who are older than 55 years, with suspected regional lymph node metastasis are excluded. The primary end point are the acute toxicities within 4 weeks after adjuvant radiation. The secondary endpoints are oncologic outcomes, surgical complications within 30 days, late toxicities, patients' quality of life and cosmetic outcomes.
Who can take part
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).
Where it is running
1 location listed.
- National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College - Beijing, Beijing Municipality, China