Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients

Not Applicable

Active, not recruiting

Interventions: Procedure: Partial mastectomy plus additional Shave Margin
Procedure: Partial mastectomy

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Shave Margin	Partial mastectomy plus additional Shave Margin	After partial mastectomy, patients will be subject to intraoperative randomization to the shave margin group where additional tissue will be resected.
No Shave Margin	Partial mastectomy	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.

Primary Outcome Measures

Name	Time	Method
Positive margin rate	immediately after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life assessment	5 years post-op about the last seven days	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.
local recurrence rates	up to 5 years	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.
patient perceived cosmesis	5 years post-op	Subjects will be asked their perception of physical appearance: poor, fair, good, or excellent.
volume of tissue resected	immediately after tissue resection	based on the sum of the volumes of tissue excised as found in the gross description of the specimens on the pathology report.

Locations (9): Loma Linda University Cancer Center
🇺🇸
Loma Linda, California, United States
William Beaumont Hospital
🇺🇸
Troy, Michigan, United States
UNC Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States
Watson Clinic Cancer and Research Center
🇺🇸
Lakeland, Florida, United States
Cleveland Clinic Akron General
🇺🇸
Akron, Ohio, United States
Women & Infants Hospital
🇺🇸
Providence, Rhode Island, United States
Wake Forest School of Medicine
🇺🇸
Winston-Salem, North Carolina, United States
Doctors Hospital at Renaissance
🇺🇸
Edinburg, Texas, United States
Thomas Jefferson University
🇺🇸
Philadelphia, Pennsylvania, United States