Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/15/2018
Start Date:July 2016
End Date:November 2021

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

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.

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.

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)
We found this trial at
9
sites
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Theodore Tsangaris, MD
Phone: 215-955-9626
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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1 Akron General Avenue
Akron, Ohio 44307
Principal Investigator: Andrew Fenton, MD
Phone: 330-344-6348
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Akron, OH
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CHapel Hill, North Carolina 27599
Principal Investigator: Krystalyn Gallagher, DO
Phone: 919-216-0817
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CHapel Hill, NC
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Edinburg, Texas 78539
Principal Investigator: Ricardo Martinez, MD
Phone: 956-362-2380
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Edinburg, TX
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Lakeland, Florida 33805
Principal Investigator: Elisabeth Dupont, MD
Phone: 863-603-4720
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Lakeland, FL
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Loma Linda, California 92354
Principal Investigator: Sharon S Lum, MD
Phone: 909-558-7117
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Loma Linda, CA
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Providence, Rhode Island 02905
Principal Investigator: Sonali Pandya, MD
Phone: 401-274-1122
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Providence, RI
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Troy, Michigan 48085
Principal Investigator: Eric Brown, MD
Phone: 248-551-5093
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Troy, MI
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Winston-Salem, North Carolina 27157
Principal Investigator: Marissa Howard-McNatt, MD
Phone: 330-344-6348
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Winston-Salem, NC
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