Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®
This is a prospective study comparing partial mastectomy performed with routine cavity shave margins and Savi Scout® localization to partial mastectomy performed with selective margins and Savi Scout® localization. The primary objective is to determine the difference in positive margin rate between the two methods. The secondary objectives are to determine the differences in the rate of re-excision, volume of tissue extracted and Breast-Q® score between the two methods. It is hypothesized that the Savi Scout® will allow for decreased volume of tissue excised when compared to routine cavity shave margins without any difference in positive margin rate or rate of re-excision.
• Women 18 years and older, and
• With Clinical stage I-II invasive breast cancer, or Stage 0 DCIS, and
• That have been diagnosed by means of core needle biopsy appropriate for breast conserving therapy, and
• Present to Cleveland Clinic Akron General.
• Subjects must have pathologically confirmed breast carcinoma or ductal carcinoma in situ.
• Performance status: ECOG 0-1
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.
• Patients may have received or may be receiving endocrine therapy.