A Registry of Intra-Operative Radiation Therapy (IORT) Using the Xoft ® Axxent ® eBx ™ System Patients

General Inclusion Criteria

• Subject must have provided written Informed Consent
• Subject must have biopsy-proven ductal carcinoma in situ (DCIS) or invasive ductal carcinoma of the breast

a. In addition to invasive ductal carcinoma, allowable invasive carcinomas are: i. Adenoid cystic (or adenocystic) carcinoma ii. Low-grade adenosquamous carcinoma iii. Medullary carcinoma iv. Mucinous (or colloid) carcinoma v. Papillary carcinoma vi. Tubular carcinoma vii. Metaplastic carcinoma viii. Micropapillary carcinoma ix. Mixed carcinoma

• Subject must be female ≥ 40 years of age
• Subject's tumor(s) must be < 3.0 cm in greatest diameter by pre-operative assessment
• Clinical staging of Subject's tumor(s) must meet AJCC Tumor Classification: Tis, T1 or T2 (< 3 cm), N0, M0
• Subject presenting with bilateral breast cancer may be enrolled if BOTH cancers meet all of the inclusion and none of the exclusion criteria
• Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
• Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as intrauterine devices, surgical contraceptives or a combination of condom and spermicide) from the time of negative pregnancy test through completion of the radiation treatment period

General Exclusion Criteria

• Subject is pregnant or nursing
• Subject has significant auto-immune disease
• Subject has a pacemaker present in the field of radiation or quadrant of the breast cancer
• Subject has multi-focal breast cancer where the sum of the individual tumor sizes (greatest diameters) are > 3 cm Subject has multi-centric breast cancer
• Subject has known lympho-vascular invasion
• Subject has invasive lobular cancer
• Subject has undergone neo-adjuvant chemotherapy or neo-adjuvant endocrine therapy for current breast cancer
• Subject has a history of recurrent breast cancer in the ipsilateral breast
• Subject has had previous radiation exposure of the involved breast
• Subject has BRCA 1 or 2 mutations. Note: Testing will only be required for subjects presenting with bilateral breast cancer; testing is not required for unilateral cancers
• Subject has contraindications for radiation
• Subject considered by the Investigator to be high-risk for breast conservation surgery and/or intra-operative radiation therapy
• Subject has participated in any other clinical investigation that is likely to confound study results or affect study outcome either at the time of IORT or for 3 months prior to IORT