Post Market Study Using the Xoft Axxent System

Post Market Clinical Study to Evaluate the Safety and Performance of the Axxent® Electronic Brachytherapy System in Women With Resected, Early Stage Breast Cancer

The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.

The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System for the delivery of radiation therapy as part of breast conserving therapy in women with resected, early stage breast cancer.

Inclusion Criteria:

• Age >50 years
• Tumor with Tis, T1, N0, M0 - (AJC Classification)
• Invasive ductal carcinoma or ductal carcinoma in situ
• Negative microscopic surgical margins of at least 1mm in all directions
• Adequate skin spacing between balloon surface and surface of the skin - (> 7mm)

Exclusion Criteria:

• Pregnancy or breast-feeding - (During the treatment portion of the study, sexually active women of childbearing age will be asked to use pregnancy prevention)
• Scleroderma, systemic sclerosis and active lupus
• Infiltrating lobular histology