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

Exclusion Criteria

• •7. Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
• •8. 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
• •1. Subject is pregnant or nursing
• •2. Subject has significant auto-immune disease
• •3. Subject has a pacemaker present in the field of radiation or quadrant of the breast cancer
• •4. 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
• •5. Subject has known lympho-vascular invasion
• •6. Subject has invasive lobular cancer
• •7. Subject has undergone neo-adjuvant chemotherapy or neo-adjuvant endocrine therapy for current breast cancer
• •8. Subject has a history of recurrent breast cancer in the ipsilateral breast
• •9. Subject has had previous radiation exposure of the involved breast
• •10. 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
• •11. Subject has contraindications for radiation
• •12. Subject considered by the Investigator to be high-risk for breast conservation surgery and/or intra-operative radiation therapy
• •13. 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