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

Launched by ALPHA TAU MEDICAL LTD. · Dec 31, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for breast cancer, specifically using a device that delivers a type of radiation directly into the tumor. This method, called diffusing alpha radiation therapy, is being studied for frail or elderly patients who have either newly diagnosed or recurrent breast cancer. The goal is to find out if this treatment can help patients who may not be able to undergo traditional surgery due to their health.

To be eligible for the trial, participants need to have a confirmed diagnosis of breast cancer with certain conditions. This includes having a tumor that is no larger than 4 centimeters and not having skin involvement. Patients must be 65 years or older, or younger if they are not fit for standard treatments. Participants will receive the new treatment and will be closely monitored throughout the study. This trial is currently recruiting patients, so those who meet the criteria and are interested may have the opportunity to join and potentially benefit from this innovative approach to care.

Gender

ALL

Eligibility 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.