Breast Cancer, Breast Carcinoma, Recurrent Breast Cancer
Conditions
Keywords
Alpha radiation, Breast cancer, Newly Diagnosed Breast Carcinoma, Breast carcinoma
Brief summary
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.
Detailed description
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
Interventions
An intratumoral insertion of radioactive sources \[Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)\]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms
Sponsors
Alpha Tau Medical LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 120 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility -DaRT seed placement | immediately following the insertion procedure | Feasibility will be determined according to the Rate of successful placement of DaRT seeds via imaging |
| Safety- Adverse events | From Day 0 | Safety will be determined according to the overall incidence of device related SAE'sgraded according to CTCAE v5.0 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - Control evaluation | 3,6,12 and 24 months | To evaluate efficacy, as determined by local control evaluation according to RECIST v1.1 |
Countries
Israel
Contacts
Primary ContactLiron Dimnik
Backup ContactAviya Hoida
Outcome results
None listed