Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients (SHAVE2)

• ClinicalTrials.gov Identifier: NCT02772731
• Recruitment Status: Active, not recruiting
• First Posted: May 13, 2016
• Last Update Posted: October 2, 2019
• Sponsor: Yale University
• Information provided by (Responsible Party): Yale University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Procedure: Partial mastectomy plus additional Shave Margin; Procedure: Partial mastectomy	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients
• Study Start Date: July 2016
• Actual Primary Completion Date: June 2018
• Estimated Study Completion Date: November 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Shave Margin; After partial mastectomy, patients will be subject to intraoperative randomization to the shave margin group where additional tissue will be resected.	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.
Active Comparator: 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.	Procedure: Partial mastectomy; Surgeons will be instructed to close after partial mastectomy with no further excision.

Outcome Measures

Primary Outcome Measures :

1. Positive margin rate [ Time Frame: 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 :

1. local recurrence rates [ Time Frame: 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.
2. patient perceived cosmesis [ Time Frame: 1 year post-op ]
   Subjects will be asked their perception of physical appearance: poor, fair, good, or excellent.
3. patient perceived cosmesis [ Time Frame: 5 years post-op ]
   Subjects will be asked their perception of physical appearance: poor, fair, good, or excellent.
4. volume of tissue resected [ Time Frame: 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.
5. Quality of Life assessment [ Time Frame: 1 year 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.
6. Quality of Life assessment [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United States, California

Loma Linda University Cancer Center

Loma Linda, California, United States, 92354

United States, Florida

Watson Clinic Cancer and Research Center

Lakeland, Florida, United States, 33805

United States, Michigan

William Beaumont Hospital

Troy, Michigan, United States, 48085

United States, North Carolina

UNC Chapel Hill

Chapel Hill, North Carolina, United States, 27599-7213

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States, 27157

United States, Ohio

Cleveland Clinic Akron General

Akron, Ohio, United States, 44307

United States, Pennsylvania

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

United States, Rhode Island

Women & Infants Hospital

Providence, Rhode Island, United States, 02905

United States, Texas

Doctors Hospital at Renaissance

Edinburg, Texas, United States, 78539

Sponsors and Collaborators

Yale University

Investigators

• Principal Investigator: Anees Chagpar, MD; Yale University

More Information

Publications:

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.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT02772731
• Other Study ID Numbers: 1602017205
• First Posted: May 13, 2016
• Last Update Posted: October 2, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Yale University:

mastectomy

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases