Alpha Radiation Emitters Device for the Treatment of Newly Diagnosed Breast Carcinoma Patients With Distant Metastases

NCT03970967 | Terminated

• 1 other identifier: CTP-BRST-01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for newly Diagnosed Breast Carcinoma patients with distant metastases

Conditions

Breast Carcinoma; Metastatic Breast Cancer; Invasive Breast Cancer; Distant Metastases.Pathology

Keywords

Breast carcinoma; Metastatic breast cancer; Invasive breast cancer; Alpha radiation; Luminal A; Luminal B; Triple negative; HER2; Breast cancer; Breast metastases

Outcome Measures

Primary Outcomes (2)

• Tumor response to DaRT

  Assessment of the rate of malignant breast tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).

  9-11 weeks post DaRT insertion.

• Adverse Events

  Assessment of the frequency, severity and causality of acute adverse events related to the DaRT treatment using the Common Terminology and Criteria for adverse events (CTCAE) version 5.0

  Day 0 - 6 months (+/-14 days)

Secondary Outcomes (8)

• Change in tumor volume.

  9-11 weeks after DaRT insertion.

• DaRT seeds placement

  Day of insertion.

• Change in quality of life: EORTC-QLQ-C30

  Day 0, 30, 70, 6 months (+/-14 days).

• Progression free survival

  6 months (+/-14 days).

• Pathological remissions.

  12 weeks after DaRT seed insertion.

Study Arms (1)

DaRT Seeds

EXPERIMENTAL

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Device: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Interventions

Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) DEVICE

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.

DaRT Seeds

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with histopathological confirmation of primary (or recurrent) invasive breast carcinoma and distant metastatic disease at diagnosis.
• Target tumor size ≤ 3.0 cm (T1-2b category);
• Morphological type: invasive breast cancer
• Luminal-type A (ER+, PR+, Her2/neu +1), HER+, luminal-type B (ER +/-, PR +/-, Her2/neu+1), or Triple negative breast carcinoma
• Measurable disease according to RECIST v1.1.
• Subjects over 45 years old.
• Subjects' ECOG Performance Status Scale is \< 2.
• Subjects' life expectancy more than 6 months.
• Platelet count ≥100,000/mm3.
• International normalized ratio of prothrombin time ≤1.8.
• Creatinine ≤1.9 mg/dL.
• Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
• Subjects are willing to sign an informed consent form.

You may not qualify if:

• T4 category with skin involvement.
• Regional lymph node metastases.
• Ductal carcinoma in situ.
• Inflammatory breast carcinoma.
• Patients with pre-irradiation of the breast.
• Acute infection disease.
• The presence of HIV, RW, HbsAg, HCV in the acute stage.
• Pregnancy or lactation.
• Serious competing (somatic) diseases incompatible according to the researcher with brachytherapy.
• Mental illness.
• Patients undergoing immunosuppressive and/or systemic corticosteroid treatment
• Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
• High probability of protocol non-compliance (in opinion of investigator).
• Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)
• Subjects not willing to sign an informed consent.

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

Study Sites (1)

A. Tsyb Medical Radiological Research Center

Obninsk, Kaluga Oblast, 249036, Russia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Aleksandr Obukhov

  A. Tsyb Medical Radiological Research Centre, (A. Tsyb MRRC), Obninsk, Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 3, 2019
• Study Start: August 28, 2019
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 18, 2024

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)