Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
This prospective, multicenter, 1:1 randomized, controlled trial is designed to evaluate the safety and effectiveness of the Breast Cancer Locator (BCL) in subjects with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS). Subjects will be randomized to breast conserving surgery (BCS) utilizing either the BCL or wire localization (WL) to guide surgery.
• Female gender
• Age \> 18 years
• Histologic diagnosis of invasive breast cancer or DCIS
• The surgeon determines that pre-operative tumor localization is required because the tumor cannot be definitively detected by palpation
• The tumor is unifocal or multifocal with satellite lesions \< or = 2 cm from primary tumor
• The tumor enhances on prone breast MRI imaging
• The tumor is ≥ 1 cm in diameter on prone breast MRI
• Subject and surgeon agree to perform BCS
• Subject voluntarily provides informed consent