Lumpectomy Followed by Intraoperative Electron Radiation Therapy (IOERT) as a Single Full Dose Partial Breast Irradiation for Early Stage, Node Negative, Invasive Breast Cancer
The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.
• Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer
• Patient agrees to evaluation of the axilla with sentinel lymph node biopsy
• Post-menopausal women age \> 60, defined as women who have experienced no menstrual period in the past 12 months.
• BRCA1 and 2 gene mutation negative, if tested. \[genetic testing is NOT required based upon personal or family history\]
• Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) \< 2.0 cm in diameter, primary T-stage of T1 (AJCC criteria)
• Grade 1, 2 acceptable
• Associated LCIS is allowed
• Estrogen receptor (ER) status of positive
• Negative margins at ink on gross pathologic examination
• Patient is node-negative, defined as N0 (i-) or N0 (i+)
• Patient must be deemed functionally and mentally competent to understand and sign the informed consent