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

A Pilot Feasibility and Safety Trial of Intratumoral Diffusing Alpha-emitter Radiation Therapy (DaRT) for the Treatment of Newly Diagnosed or Recurrent Breast Carcinoma in Frail or Elderly Patients.

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of newly diagnosed or Recurrent Breast Carcinoma in frail or elderly patients.

This is a Prospective Open label Single arm multi-center interventional study. The study is designed to evaluate the Feasibility and Safety of DaRT seeds for the treatment of newly diagnosed or Recurrent Breast Carcinoma in frail or elderly patients.

The study will be comprised of a screening period, DaRT insertion visit, acute follow-up phase of 4- 8 weeks and a long-term follow up phase of 24 months. The total duration of the study will be 24 months from the DaRT insertion procedure.

A total of 10 subjects will be enrolled from all breast cancer subtypes (HR+/HER-2-, HR+/HER-2+, HR-/HER-2-, and HR-/HER-2-.). No formal interim analysis is planned for this study.

Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion. The patients will be monitored for a period of 24 months post insertion

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

Exclusion Criteria:

• T4 category with skin involvement.
• Ductal carcinoma in situ.
• Inflammatory breast carcinoma.
• Longest tumor diameter >4 cm.
• Patients with prior radiation to the same area within the past 6 months.
• Has a known additional malignancy that is progressing or requires active treatment.
• Patients undergoing immunosuppressive and/or systemic corticosteroid treatment except for steroid inhalations for treatment of asthma or lung disease
• Subjects not willing to sign an informed consent.