Treatment of Breast Cancer with Alpha Radiation in Elderly or Frail Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the feasibility and safety of using diffusing alpha radiation therapy (DaRT) for treating newly diagnosed or recurrent breast carcinoma in frail or elderly patients. It is a prospective, open-label, single-arm, multi-center interventional study that will enroll 10 subjects with various breast cancer subtypes. Participants will undergo a DaRT insertion procedure, followed by an acute follow-up phase of 4-8 weeks and a long-term follow-up phase lasting 24 months. The study aims to monitor the patients for safety and treatment outcomes over the entire duration.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hadassah Medical Center
  Jerusalem, Israel Recruiting

Study contacts

• Study coordinator: Liron Dimnik
• Email: LironD@alphatau.com
• Phone: +972542688602

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.