Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS)

Exclusion Criteria

• •1. Age less than 50 years.
• •2. Premenopausal or uncertain menopausal status.
• •3. A known deleterious mutation in BRCA 1 and/or BRCA 2.
• •4. Clinical tumor size \> 2.0 cm in greatest diameter on staging ultrasound.
• •5. Tumor histology limited to lobular carcinoma only.
• •6. Clinically positive axillary nodes (cN+).
• •7. Lymphovascular invasion on biopsy.
• •8. Pure ductal or lobular carcinoma in situ on biopsy.
• •9. Extensive intraductal component on biopsy.
• •10. Neoadjuvant hormonal manipulation or chemotherapy.
• •11. Prior non basal cell or squamous cell skin cancers within 5 years.
• •12. More than one primary tumor in different quadrants of the same breast.
• •13. Diffuse microcalcifications on mammography.
• •14. Paget's disease of the nipple.
• •15. Previous irradiation to the ipsilateral breast.
• •16. Presence of an ipsilateral breast implant or pacemaker.
• •17. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.
• •18. Estrogen receptor status (ER) not known.
• •19. Currently pregnant or lactating.
• •20. Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol.
• •21. Geographic inaccessibility for follow-up.
• •22. Lack of preoperative staging with breast and axillary ultrasound.
• •23. Inability to adequately plan the patient for the experimental technique.
• •24. Prior breast cancer.