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

NCT03975179 | Recruiting

• 1 other identifier: KC19EEDT0031
• Study Type: interventional
• Target: 1,292
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Breast Cancer

Keywords

frozen section biopsy; resection margin; breast conserving surgery

Outcome Measures

Primary Outcomes (1)

• Resection margin status

  Margin status data will be obtained from pathology report. Positive margin is defined as "no ink on tumor" for DCIS and invasive cancer. A close margin of any distance is defined as a negative margin

  2 weeks after primary surgery

Secondary Outcomes (7)

• Reoperation rate

  2 months after primary surgery

• Operation time

  Immediately after primary surgery

• Cost effectiveness

  3 months after primary surgery

• Resection volume

  3 months after primary surgery

• Number of patients with residual cancer after reoperation

  3 months after primary surgery

Other Outcomes (1)

• Local recurrence

  5 years after primary surgery

Study Arms (2)

Frozen section omission

EXPERIMENTAL

Intraoperative frozen section biopsy of resection margin will not be performed

Procedure: Omission of intraoperative frozen section biopsy for margin status

Frozen section

ACTIVE COMPARATOR

Intraoperative frozen section biopsy of resection margin will be performed. Margin evaluation of superior, medial, lateral, inferior margin is recommended but will follow surgeon's discretion.

Procedure: Frozen section biopsy for margin status

Interventions

Omission of intraoperative frozen section biopsy for margin status PROCEDURE

Omitting intraoperative frozen section biopsy for margin status in patients undergoing breast conserving surgery

Frozen section omission

Frozen section biopsy for margin status PROCEDURE

Performing intraoperative frozen section biopsy for margin status in patients undergoing breast conserving surgery

Frozen section

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Korean Breast Cancer Study Group: collaborator

Study Sites (2)

Ilsan Paik Hospital

Goyang-si, South Korea

RECRUITING

Seoul St. Mary's Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• Yoo TK, Kang YJ, Jeong J, Song JY, Kang SH, Lee HY, Kim ET, Yi O, Lee HB, Choi S, Park HS, Gwak G, Kim JI, Kim MK, Lee J, Kang HJ, Chae BJ. A Randomized Controlled Trial for Doing vs. Omitting Intraoperative Frozen Section Biopsy for Resection Margin Status in Selected Patients Undergoing Breast-Conserving Surgery (OFF-MAP Trial). J Breast Cancer. 2021 Dec;24(6):569-577. doi: 10.4048/jbc.2021.24.e51.

  PMID: 34979601 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Margins of Excision

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Byung Joo Chae

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Byung Joo Chae

CONTACT

82 2 3410-3479; bj.chae@samsung.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 5, 2019
• Study Start: September 24, 2020
• Primary Completion: June 1, 2023
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: End of recruitment - 10 years after end of trial
• Access Criteria: co-investigators

Locations

KR (2)