Omitting vs. Doing Intraoperative Frozen Section Biopsy for Margin Status in Breast Conserving Surgery
A Randomized Controlled Trial for Doing vs. Omitting Intraoperative Frozen Section Biopsy For Resection MArgin Status in Selected Patients Undergoing Breast Conserving Surgery
Samsung Medical Center
1,292 participants
Sep 24, 2020
INTERVENTIONAL
Conditions
Summary
* Study phase: 3 * Indication: Breast cancer patients undergoing breast conserving surgery * Primary objectives: To determine the effect of selective omission of intraoperative margin evaluation via frozen section on margin positive rate Secondary objectives: To determine the effect of selective omission of intraoperative margin evaluation via frozen section on reoperation rate, local recurrence rate, operation time, resection volume, medical cost and patient quality-of life * Hypothesis: Omitting intraoperative margin evaluation via frozen section biopsy in selected breast cancer patients does not increase margin positive rate * Study design: Randomized controlled trial * Sample size: 1292 patients * Procedures: breast conserving surgery +/- margin frozen section biopsy (+/- additional resection)
Eligibility
Inclusion Criteria5
- Pathologically confirmed breast cancer by core needle biopsy with clinical stage T1-3 by American Joint Committee on Cancer(AJCC) 8th edition
- Candidate of breast-conserving surgery
- Daughter nodule within ≤ 1cm distance of main mass on breast MRI
- Non-mass enhancement extent within ≤ 1cm distance of main mass on breast MRI
- Ability to understand and willing to sign a written informed consent document : Patients who consent about deciding whether frozen biopsy will be performed by randomization
Exclusion Criteria10
- cT4 tumors (AJCC 8th edition)
- Cancer diagnosis confirmed by vacuum-assisted biopsy or surgical biopsy
- Initial operation plan being total mastectomy (conversion to total mastectomy after intraoperative frozen section biopsy is acceptable)
- Personal history of ipsilateral breast cancer
- Ductal carcinoma in situ component on CNB result
- Lobular carcinoma (invasive, in situ)
- Neoadjuvant chemotherapy
- Lesion with microcalcification (microcalcification that is only contained inside the cancer mass is acceptable)
- Multicentric tumor, however a daughter nodule within ≤ 1cm distance on breast MRI is acceptable
- Non-mass enhancement extent wider than 1cm distance of main mass on breast MRI
Interventions
Omitting intraoperative frozen section biopsy for margin status in patients undergoing breast conserving surgery
Performing intraoperative frozen section biopsy for margin status in patients undergoing breast conserving surgery
Locations(2)
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NCT03975179