This study is being done to assess the safety and efficacy (effectiveness) of the Xoft Axxent eBx System when used for single-fraction IORT (a form of radiation treatment where the radiation is given in the operating room at the time of surgery) in early stage breast cancer after the removal of a breast tumor. . Efficacy will be evaluated by comparing ipsilateral (same side) tumor recurrence rates (cancer returning in the same side) for subjects treated with IORT to a recurrence rate based on long term published data. The radiation therapy treatments will be administered with electronic brachytherapy (a form of radiotherapy where a radiation source is placed inside or next to the area requiring treatment) using the FDA cleared Xoft Axxent System. Once the tumor or lump is removed from the breast, the Xoft balloon Applicator device with the un-inflated balloon at the tip will be inserted into the cavity left by removal of the lump. Once in place, the balloon is inflated with saline. The balloon will remain inflated for the entire time during radiation treatment (about 20 minutes). By placing the balloon inside the cavity left by removal of the tumor, the radiation source can be placed directly within the part of the breast that has the highest risk for tumor recurrence. Patient follow-up visits will occur at one month, six months, twelve months, eighteen months, two years, three years, four years, and five years. At each visit, patient will be asked to fill out a Quality of Life Questionnaire. It is estimated that each patient who enrolls in the study and completes all required follow-up visits will be participating for five years.
A Safety and Efficacy Study of Intra-Operative Radiation Therapy (IORT) Using the Xoft® Axxent® eBx™ System at the Time of Breast Conservation Surgery for Early Stage Breast Cancer
066-12Principal Investigator: Conducted at:
Long Beach MemorialCurrently enrolling additional patients: