Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients

NCT ID: NCT02772731

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2024-11-30

Brief Summary

Breast cancer is the most common malignancy affecting women in the US. Surgical management is the mainstay of therapy, and in general consists of resection of the primary tumor with either a partial mastectomy (aka "lumpectomy") or a total mastectomy.

The investigators hypothesize that routine shave margins during partial mastectomy will significantly reduce positive margin rate. A positive margin means that cancerous cells were detected at the edge of the excised area. This generally mandates a return to the operating room for re-excision.

Detailed Description

Some authors have investigated, in a retrospective fashion, the use of routine shave margins, where surgeons routinely take additional margins at the time of the initial partial mastectomy as a means of obtaining negative margins. While these retrospective studies have found that positive margin rates declined using this technique, opponents to this technique wonder if this truly results in a higher negative margin rate without compromising cosmesis or increasing tissue volume removed. As these studies were retrospective, it was possible that the initial resection was smaller than what those who do not routinely take shave margins would resect. No one had evaluated the impact of further resection on operative time, nor in a blinded fashion, evaluated cosmesis. Further, there had yet to be a prospective study to evaluate the impact of this on local recurrence rates. Hence, the investigators performed a prospective randomized controlled trial of this technique at Yale. The data from this study, published in the New England Journal of Medicine, found that the technique cut positive margin and re-excision rates in half. Some wondered, however, about the external generalizability of these findings, particularly in non-academic settings. Hence, a multicenter trial to validate these findings is warranted.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Shave Margin

After partial mastectomy, patients will be subject to intraoperative randomization to the shave margin group where additional tissue will be resected.

Group Type: EXPERIMENTAL

Partial mastectomy plus additional Shave Margin

Intervention Type: PROCEDURE

For the shave group, additional superior, inferior, medial and lateral margins will be removed, oriented, and sent for pathologic evaluation at the local site. Resection of additional anterior and posterior margins will be left to surgeon discretion, as this will depend on if skin or fascia was taken. All surgeons participating in the study will be educated on the expectation of what is considered a "shave margin". A shave margin is defined as an additional segment of breast tissue taken from each of the superior, inferior, medial, and lateral aspects of the cavity, such that the entire circumference of the cavity is re-excised following this procedure. Orientation of each shaved margin will be done to mark the true margin.

No Shave Margin

After partial mastectomy, patients will be subject to intraoperative randomization to the no shave margin group, where after initial surgery, no further tissue will be removed.

Group Type: ACTIVE_COMPARATOR

Partial mastectomy

Intervention Type: PROCEDURE

Surgeons will be instructed to close after partial mastectomy with no further excision.

Interventions

Partial mastectomy plus additional Shave Margin

For the shave group, additional superior, inferior, medial and lateral margins will be removed, oriented, and sent for pathologic evaluation at the local site. Resection of additional anterior and posterior margins will be left to surgeon discretion, as this will depend on if skin or fascia was taken. All surgeons participating in the study will be educated on the expectation of what is considered a "shave margin". A shave margin is defined as an additional segment of breast tissue taken from each of the superior, inferior, medial, and lateral aspects of the cavity, such that the entire circumference of the cavity is re-excised following this procedure. Orientation of each shaved margin will be done to mark the true margin.

Intervention Type: PROCEDURE

Partial mastectomy

Surgeons will be instructed to close after partial mastectomy with no further excision.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Breast cancer, stage 0-3, deemed a surgically appropriate candidate for partial mastectomy with planned procedure for the same

2. Women ≥ 18 years of age

3. Ability to understand and the willingness to sign a written informed consent document.

Exlusion Criteria

1. Total mastectomy

2. Known metastatic disease

3. Bilateral synchronous breast cancer

4. Multicentric cancers requiring double lumpectomy

5. Previous history of breast cancer (even in the other breast)

6. Patients receiving Intraoperative radiation therapy (IORT)

7. Patients who had excisional biopsy for diagnosis of their cancer (I.e., instead of a core biopsy)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anees Chagpar, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Loma Linda University Cancer Center

Loma Linda, California, United States

Watson Clinic Cancer and Research Center

Lakeland, Florida, United States

William Beaumont Hospital

Troy, Michigan, United States

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Cleveland Clinic Akron General

Akron, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Women & Infants Hospital

Providence, Rhode Island, United States

Doctors Hospital at Renaissance

Edinburg, Texas, United States

Countries

United States

References

Chagpar AB, Killelea BK, Tsangaris TN, Butler M, Stavris K, Li F, Yao X, Bossuyt V, Harigopal M, Lannin DR, Pusztai L, Horowitz NR. A Randomized, Controlled Trial of Cavity Shave Margins in Breast Cancer. N Engl J Med. 2015 Aug 6;373(6):503-10. doi: 10.1056/NEJMoa1504473. Epub 2015 May 30.

Reference Type: BACKGROUND

PMID: 26028131 (View on PubMed)

Other Identifiers

1602017205

Identifier Type: -

Identifier Source: org_study_id