| Exclusion Criteria: | 1) Distance from the balloon surface to the surface of the skin equal to or less than 5mm as determined by CT imaging.
2) Distant metstases.
3) Invasive or In-situ lobular carcinoma.
4) Nonepithelial breast malignancies such as sarcoma or lymphoma.
5) DCIS that is multicentric in the ipsilateral breast.
6) Pregnant or lactating.
7) Prior non-hormonal therapy for the present breast cancer, including radiation therapy and/or chemotherapy.
8) Collagen vascular diseases. Specifically systemic lupus erythematosus (SLE), systemic sclerosis (scleroderma), CREST Syndrome (calcinosis, Raynaud phenomenon, esophageal dysfunction, sclerodactyly, telangiectasia, and the presence of anticentromere antibodies) in limited systemic sclerosis, polymyositis, dermatomyositis with a CPK level above normal or with an active skin rash, inclusion-body myositis, or amyloidosis are excluded from the study.
9) Coexisting medical conditions with life expectancy equal to or less than 2 years.
10) Serious psychiatric disorder with active psychosis or known active drug addiction.
11) Previously treated contalateral breast carcinoma.
12) Synchronous bilateral breast carcinoma.
13) Other malignancy, except non-melanoma skin cancer, < 5 years prior to participation in the study; the disease free interval from any prior carcinoma must be continuous.
14) Patients with diffuse disease: a. >1 quadrant of DCIS or b. >5 cm in diameter on gross pathology measurement, or c. Unable to clear suspicious microcalcifications (calcifications seen on the preoperative stereotactic-placed wire bracketed mammogram that are not seen on the post lumpectomy mammogram within the bracketed wires). |