NCT05603078 A Prospective Study of Preoperative Tumor-bed Boost Followed by Oncoplastic Surgery and Adjuvant Whole Breast Radiotherapy for Early Stage Breast Cancer (BIRKIN)
| NCT ID | NCT05603078 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Breast Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2022-06-21 |
| Primary Completion | 2026-07-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 102 participants in total. It began in 2022-06-21 with a primary completion date of 2026-07-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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).
Contact & Investigator
Jing Wang, M.D.
STUDY CHAIR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT05603078 clinical trial?
This trial is open to female participants only, up to 55 Years, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05603078 currently recruiting?
Yes, NCT05603078 is actively recruiting participants. Contact the research team at howelu1349@hotmail.com for enrollment information.
Where is the NCT05603078 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05603078 clinical trial?
NCT05603078 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The principal investigator is Jing Wang, M.D. at Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 102 participants.