Comparing frozen section biopsy versus no biopsy during breast conserving surgery for breast cancer
A Randomized Controlled Trial for Doing vs. Omitting Intraoperative Frozen Section Biopsy For Resection MArgin Status in Selected Patients Undergoing Breast Conserving Surgery
This study tests whether skipping a quick tissue test during breast cancer surgery affects the chances of needing more surgery later for patients who are having breast-conserving surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1292 (estimated) |
| Ages | 19 Years to 70 Years |
| Sex | Female |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Goyang-si and 1 other locations) |
| Trial ID | NCT03975179 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of omitting intraoperative frozen section biopsy on margin status during breast conserving surgery for breast cancer patients. It aims to determine whether not performing this biopsy increases the rate of positive margins, which could necessitate further surgery. The study is a randomized controlled trial involving 1292 patients, assessing various outcomes including reoperation rates, local recurrence, operation time, and patient quality of life. Participants will be randomly assigned to either receive the biopsy or not during their surgical procedure.
Who should consider this trial
Good fit: Ideal candidates are women with pathologically confirmed breast cancer, clinical stage T1-3, who are eligible for breast conserving surgery.
Not a fit: Patients with advanced tumors (cT4), those requiring total mastectomy, or with certain specific breast cancer characteristics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to less invasive surgical procedures and improved patient outcomes in breast cancer treatment.
How similar studies have performed: Other studies have explored similar approaches, but this specific comparison of omitting frozen section biopsy in breast conserving surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Goyang-si and 1 other locations
- Ilsan Paik Hospital — Goyang-si, South Korea (Recruiting)
- Seoul St. Mary's Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Byung Joo Chae — Samsung Medical Center
- Study coordinator: Byung Joo Chae
- Email: bj.chae@samsung.com
- Phone: 82 2 3410-3479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.