This randomized phase II trial studies breast conservation surgery (BCS) with or without cavity shave margins (CSM) in treating patients with newly diagnosed stage 0-II breast cancer. BCS, also known as lumpectomy, is the removal of only the tumor tissues from the breast. CSM involves the additional removal of thin pieces of tissue around the edges of the tumor after the tumor has been removed. CSM during BCS may reduce the risk of positive margins (cancer cells along the edge of the tissue) better than BCS alone which may lower the risk of the tumor coming back.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02462200.
PRIMARY OBJECTIVES:
I. To evaluate the utility of routine CSM in BCS and its impact on positive margin rates.
II. To measure post-operative patient perceptions using a validated, BCS-specific survey tool and a novel three-dimensional breast imaging technique.
III. To compare the intraoperative near infrared (NIR) fluorescence information obtained from the goggle system with pathologic tissue exam results.
SECONDARY OBJECTIVES:
I. To examine the relationship between CSM and volume of tissue excised in association with post-operative aesthetic outcomes.
II. To assess the cost-effectiveness of routine CSM in BCS in regard to operative time, specimen processing, and resource usage.
III. To analyze potential cancer biomarkers in peripheral blood samples in association with disease status and tumor characteristics.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo BCS (partial mastectomy, lumpectomy, or local excisional biopsy).
ARM II: Patients undergo BCS (partial mastectomy, lumpectomy, or local excisional biopsy) with additional CSM.
Following BCS with or without CSM, all patients receive indocyanine green intravenously (IV) and undergo NIR fluorescence imaging per standard of care.
After completion of study treatment, patients are followed up for 6-12 months.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorJulie A. Margenthaler
