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

Breast Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06202118
• Other study ID #: CTP-BRST-07
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: June 2026

Study information

• Verified date: December 2023
• Source: Alpha Tau Medical LTD.
• Contact: Liron Dimnik
• Phone: +972542688602
• Email: LironD[@]alphatau.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Recurrent Breast Cancer

Intervention

Device:
• Diffusing Alpha Radiation Emitters Therapy (DaRT)
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

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Alpha Tau Medical LTD.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility -DaRT seed placement	Feasibility will be determined according to the Rate of successful placement of DaRT seeds via imaging	immediately following the insertion procedure
Primary	Safety- Adverse events	Safety will be determined according to the overall incidence of device related SAE'sgraded according to CTCAE v5.0 criteria	From Day 0
Secondary	Efficacy - Control evaluation	To evaluate efficacy, as determined by local control evaluation according to RECIST v1.1	3,6,12 and 24 months