NCT05603078

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, non-controlled, feasitility study. The tumor-bed boost part of the radiotherpay is put forward, 7-14 days before the definitive surgery. A single dose of 10Gy is prescribed to the tumor bed. In order to identify the tumor accurately, MRI guided radiotherapy is applied under the MR-linac. The breast surgery is planned after recovery from radiation induced acute toxicity, within 14 days. The surgeons would undertake lumpectomy only or an additional oncoplastic surgery, with axillary nodal evaluation with sentinal nodal biopsy or dissection. After wound healing, postoperative whole breast radiotherapy is administered, within 6 weeks following surgery. The dose is 26Gy/5.2Gy/5 fractions. Adjuvant systemic therapy is held until the end of the radiotherapy, no more than 12 weeks from surgery implementation.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
RADIATION	Preoperative MRI-guided tumor-bed boost and postopreative ultra-hypofractionated radiotherapy (26 Gy/5.2Gy/5)	Preoperative tumor-bed boost was performed under MRI Linac, and a single dose of 10Gy is prescribed. The postoperative radiotherapy of 26Gy/5.2Gy/5 fractions is within 6 weeks following surgery. Adjuvant chemotherapy, targeted therapy and endocrine therapy are initiated no more than 12 weeks after surgery.

Timeline

• Start date: 2022-06-21
• Primary completion: 2026-07-19
• Completion: 2028-07-01
• First posted: 2022-11-02
• Last updated: 2022-11-02

Locations

1 site across 1 country: China