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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Breast Carcinoma; Recurrent Breast Cancer
• Intervention / Treatment: Device: Diffusing Alpha Radiation Emitters Therapy (DaRT)

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

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liron Dimnik; Phone Number: +972542688602; Email: LironD@alphatau.com
• Study Contact Backup: Name: Aviya Hoida; Phone Number: +972547869466; Email: aviyah@alphatau.com

Study Locations

• Israel
  • Jerusalem, Israel, 9777605
    • Hadassah Medical Center
    • Contact: Tanir Michal Eloise, MD; Email: tanir@hadassah.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DaRT Seeds; Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy - Control evaluation	To evaluate efficacy, as determined by local control evaluation according to RECIST v1.1	3,6,12 and 24 months

Collaborators and Investigators

• Sponsor: Alpha Tau Medical LTD.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 31, 2023
• First Submitted That Met QC Criteria: December 31, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Breast cancer; Alpha radiation; Breast carcinoma; Newly Diagnosed Breast Carcinoma
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Breast Diseases; Breast Neoplasms; Carcinoma
• Other Study ID Numbers: CTP-BRST-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No