Treatment of Breast Cancer with Alpha Radiation in Elderly or Frail 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.
This study is testing a new type of radiation treatment for breast cancer to see if it's safe and effective for older or frail patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 65 Years to 120 Years |
| Sex | All |
| Sponsor | Alpha Tau Medical LTD. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT06202118 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 65 and older, or younger patients who are unfit for standard surgical treatment, with a single invasive breast tumor that meets specific criteria.
Not a fit: Patients with multiple lesions, those whose tumors are resectable, or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for elderly or frail patients with breast cancer who are not candidates for traditional surgery.
How similar studies have performed: While the use of alpha radiation in cancer treatment is an emerging approach, this specific application in frail or elderly breast cancer patients is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jerusalem
- Hadassah Medical Center — Jerusalem, Israel (Recruiting)
Study contacts
- Study coordinator: Liron Dimnik
- Email: LironD@alphatau.com
- Phone: +972542688602
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.