Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients

Breast Cancer Clinical Trial

— SHAVE2  

Official title:

A Multicenter Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02772731
• Other study ID #: 1602017205
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: July 2024
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• 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.
• Partial mastectomy
Surgeons will be instructed to close after partial mastectomy with no further excision.

Locations

Country	Name	City	State
United States	Cleveland Clinic Akron General	Akron	Ohio
United States	UNC Chapel Hill	Chapel Hill	North Carolina
United States	Doctors Hospital at Renaissance	Edinburg	Texas
United States	Watson Clinic Cancer and Research Center	Lakeland	Florida
United States	Loma Linda University Cancer Center	Loma Linda	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Women & Infants Hospital	Providence	Rhode Island
United States	William Beaumont Hospital	Troy	Michigan
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive margin rate	The effect is positive margin rate post-surgery as measured by local pathological reports. Positive margins were defined as tumor touching the edge of the specimen that was removed in patients with invasive cancer and tumor that was within 2 mm of the edge of the specimen removed in those with ductal carcinoma in situ.	immediately after surgery
Secondary	local recurrence rates	Patients will be assessed for local recurrence based on physical examination, mammography, and follow up phone calls. This is a composite score with only one outcome and only one unit (respondents). A positive results from any of these methods indicates recurrence.	up to 5 years
Secondary	patient perceived cosmesis	Subjects will be asked their perception of physical appearance: poor, fair, good, or excellent.	1 year post-op
Secondary	patient perceived cosmesis	Subjects will be asked their perception of physical appearance: poor, fair, good, or excellent.	5 years post-op
Secondary	volume of tissue resected	based on the sum of the volumes of tissue excised as found in the gross description of the specimens on the pathology report.	immediately after tissue resection
Secondary	Quality of Life assessment	Quality of Life Questionnaire measures quality of life over the past 7 days and includes 75 questions that are answered on a Likert scale. Questions assess physical, social, emotional and functional well-being in addition to cosmetic and physical appearance and questions regarding the surgery. Higher scores indicate a higher quality of life.	1 year post-op about the last seven days
Secondary	Quality of Life assessment	Quality of Life Questionnaire measures quality of life over the past 7 days and includes 75 questions that are answered on a Likert scale. Questions assess physical, social, emotional and functional well-being in addition to cosmetic and physical appearance and questions regarding the surgery. Higher scores indicate a higher quality of life.	5 years post-op about the last seven days