A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.

Inclusion Criteria

• •Histologically confirmed invasive breast tumor with no involvement of skin within 12 months.
• •Tumor size ≤ 4 centimeters in the longest diameter.
• •Tumor is not deemed as resectable with radical surgery or the patient does not wish to go through surgery
• •De-novo or recurrent lesions.
• •Single lesion per quadrant per subject.
• •Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds.
• •Interstitial implant indication validated by multidisciplinary team.
• •ECOG Performance Status ≤3.
• •Life expectancy ≥12 months.
• •Women Age ≥65 or younger if unfit for standard of care.
• •Willing and have the ability to provide signed Informed Consent.
• •Blood tests values:
• •* Leucocytes ≥3000mm3,
• •* Absolute neutrophil count ≥1500mm3,
• •* Platelets ≥100,000 mm3,
• •* Total bilirubin ≤ 1.5xULN,
• •* AST, SGOT, SGPT ≤2.5xULN, If Alkaline Phosphatase ≤ 4xULN, then transaminases are normal.
• •* Creatinine ≤ 2.0xULN.
• •* INR or Prothrombin time ≤1.5xULN