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

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ClinicalTrials.gov Identifier: NCT02772731
Recruitment Status : Active, not recruiting
First Posted : May 13, 2016
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

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 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

Resource links provided by the National Library of Medicine


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.




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.



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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772731


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

Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02772731     History of Changes
Other Study ID Numbers: 1602017205
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
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