At a glance
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A Multicenter Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients
In Brief
A clinical study evaluating Partial mastectomy plus additional Shave Margin and Partial mastectomy for Breast Cancer. Completed, enrolled 400 participants across 9 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
Surgeons will be instructed to close after partial mastectomy with no further excision.