Clinical trial · Interventional
A Prospective Study of Preoperative Tumor-bed Boost Followed by Oncoplastic Surgery and Adjuvant Whole Breast Radiotherapy for Early Stage Breast Cancer (BIRKIN)
A Prospective Study of Preoperative MRI Linac-based Tumor-bed Boost Followed by Breast-conservative Oncoplastic Surgery and Adjuvant Ultra-hypofractionated Whole Breast Radiotherapy for Early Stage Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative MRI-guided tumor-bed boost and postopreative ultra-hypofractionated radiotherapy (26 Gy/5.2Gy/5) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- preoperative tumor-bed boost
- description
- The participants receive preoperative tumor-bed boost, oncoplastic surgery and adjuvant WBRT±RNI.
- interventionNames
- Radiation: Preoperative MRI-guided tumor-bed boost and postopreative ultra-hypofractionated radiotherapy (26 Gy/5.2Gy/5)
Primary outcomes (1)
- measure
- The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree)
- timeFrame
- until 4 weeks of postoperative radiotherapy
- description
- We will record the incidence of ≥ 2 degree radiation-associated acute toxicity, such as breast or chest wall oedema, acute dermatitis, breast pain,itch of breast skin. The incidence of all the above is the primary outcome.
Secondary outcomes (9)
- measure
- Local recurrence rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients diagnosed with invasive breast cancer; 2. cN0 based on clinical physical examination combined with at least two imaging tests, or axillary fine-needle biopsy proved pN0; 3. Patients who plan to receive breast-conserving surgery or breast-conserving oncoplastic surgery; 4. No distant metastasis; 5. The primary tumour\> 5mm from the skin, without invasion of the ribs or intercostal muscles; 6. No neoadjuvant systemic therapy; 7. Patients who can tolerate MRI; 8. Life expectancy ≥5 years; 9. 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.); 10. Patients are willing to cooperate to follow up; 11. Patients should sign the informed consent; 12. Women of childbearing age need effective contraception. Exclusion Criteria: 1. Concurrent active connective tissue disease; 2. Patients who had radiotherapy to the ipsilateral breast or adjacent areas before; 3. 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)); 4. 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).
References
Publications (1)
- DERIVEDDong H, Jing H, Wang XY, Kong XY, Wang YP, Zhai YR, Che SN, Fang Y, Wang SL, Wang J. Exploring the feasibility of preoperative tumor-bed boost, oncoplastic surgery, and adjuvant radiotherapy schedule in early-stage breast cancer: a phase II clinical trial. Int J Surg. 2025 Jan 1;111(1):382-393. doi: 10.1097/JS9.0000000000002073. PMID 39264581