This randomized phase III trial studies how well routine shave margins work compared to standard partial mastectomy in reducing positive margins and re-excision rate in patients with stage 0-III breast cancer. Currently, some surgeons take extra tissue called "shave margins" as part of their normal practice during a partial mastectomy. Taking routine shave margins may work better in reducing the chances of having positive margins and needing to go back to the operating room for a second surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02772731.
PRIMARY OBJECTIVES:
I. To determine whether routine shave margins in breast cancer patients undergoing partial mastectomy will result in more optimal surgical treatment of breast cancer patients, as defined by reduced positive margin rates and a reduced need for re-excision.
SECONDARY OBJECTIVES:
I. To determine the effect of routine shave margins on (a) local recurrence rates, (b)
patient-perceived cosmesis, (c) quality of life, (d) volume of resection, (e) complication rates (with hematomas and seromas requiring drainage), and (f) time between initial surgery and adjuvant therapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo partial mastectomy with additional shave excision.
ARM II: Patients undergo partial mastectomy with no additional shave excision.
After completion of study treatment, patients are followed up at 1 and 5 years.
Lead OrganizationYale University
Principal InvestigatorAnees B. Chagpar
