Journal
JOURNAL OF BREAST CANCER
Volume 24, Issue 6, Pages 569-577Publisher
KOREAN BREAST CANCER SOC
DOI: 10.4048/jbc.2021.24.e51
Keywords
Breast Neoplasms; Frozen Sections; Margins of Excision; Mastectomy; Segmental
Categories
Funding
- Korean Breast Cancer Society
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This study is a phase III, randomized controlled, parallel-group, multicenter non-inferiority clinical trial aimed at determining if omitting frozen section biopsy for intraoperative margin evaluation in selected patients is not inferior to performing frozen section biopsy in terms of resection margin positivity rate.
Purpose: Intraoperative frozen section biopsy is used to reduce the margin positive rate and re-excision rate and has been reported to have high diagnostic accuracy. A majority of breast surgeons in the Republic of Korea routinely perform frozen section biopsy to assess margins intraoperatively, despite its long turnaround time and high resource requirements. This study aims to determine whether omitting frozen section biopsy for intraoperative margin evaluation in selected patients is non-inferior to performing frozen section biopsy in terms of resection margin positivity rate. Methods: This study is a phase III, randomized controlled, parallel-group, multicenter non-inferiority clinical trial. Patients meeting the inclusion criteria and providing written informed consent will be randomized to the frozen section biopsy or frozen section biopsy omission group after lumpectomy. Patients with clinical stage T1-T3 disease who are diagnosed with invasive breast cancer by core-needle biopsy and plan to undergo breast-conserving surgery will be included in this study. If a daughter nodule, non-mass enhancement, or microcalcification is identified on preoperative imaging, these features must be within 1 cm of the main mass for inclusion in the trial. The target sample size is 646 patients per arm. The primary endpoint will be the resection margin positive rate, and the secondary endpoints include the reoperation rate, operating time, residual cancer after reoperation, residual cancer after re-excision according to the frozen section biopsy result, resection volume, patient quality of life, and cost-effectiveness. Discussion: This is the first randomized clinical trial utilizing frozen section biopsy for intraoperative margin evaluation and aims to determine the non-inferiority of omitting frozen section biopsy in selected patients compared to performing frozen section biopsy. We expect that this trial will help surgeons perform the procedure more efficiently while ensuring patient safety.
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