Pilot Study of Intratumoral Diffusing Alpha Radiation Therapy DaRT for Treating New or Recurrent Breast Cancer in Frail or Elderly Patients

What this Trial Is About

Researchers are evaluating a unique cancer treatment using an intratumoral diffusing alpha radiation emitter device called DaRT for patients with newly diagnosed or recurrent breast carcinoma who are frail or elderly. This prospective, open-label, single-arm, multi-center interventional study aims to assess the feasibility and safety of DaRT seeds in this patient group, including breast cancer subtypes such as HRHER-2-, HRHER-2, HR-HER-2-, and HR-HER-2. Participants will undergo a screening period followed by the DaRT seeds insertion procedure directly into the tumor. After insertion, there is an acute follow-up phase lasting 4 to 8 weeks, then a long-term follow-up phase extending up to 24 months. The total study duration is 24 months from the time of the DaRT insertion. A total of 10 participants will be enrolled, and all will receive the intratumoral DaRT seeds treatment. Throughout the study, participants will be monitored regularly to evaluate the placement feasibility of the DaRT seeds immediately after insertion and to track any adverse events from day 0. Researchers will assess disease control at 3, 6, 12, and 24 months post-treatment. Blood tests and clinical evaluations will be conducted as part of screening and follow-up. The study does not include a control group or masking.

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