Omitting vs. Doing Intraoperative Frozen Section Biopsy for Margin Status in Breast Conserving Surgery

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 Criteria:

* 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 Criteria:

* 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

Conditions2

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