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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03970967
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : February 17, 2022
Sponsor:
Information provided by (Responsible Party):
Alpha Tau Medical LTD.

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

Condition or disease Intervention/treatment Phase
Breast Carcinoma Metastatic Breast Cancer Invasive Breast Cancer Distant Metastases.Pathology Device: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) Not Applicable

Detailed Description:

This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)] inserted into malignant breast lesions.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Histopathological confirmed invasive breast tumors with no involvement of skin will be treated using DaRT seeds.

The primary effectiveness endpoint of the study is the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 9-11 weeks after DaRT seed insertion.

Safety will be assessed by the cumulative frequency, severity and causality of acute adverse events related to the DaRT treatment of adverse events (AEs) observed including the follow-up period.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Newly Diagnosed Breast Carcinoma Patients With Distant Metastases
Actual Study Start Date : November 28, 2019
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : October 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
 Device: Device: Radiation: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Tumor response to DaRT [ Time Frame: 9-11 weeks post DaRT insertion. ]
    Assessment of the rate of malignant breast tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).

  2. Adverse Events [ Time Frame: Day 0 - 6 months (+/-14 days) ]
    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


Secondary Outcome Measures :
  1. Change in tumor volume. [ Time Frame: 9-11 weeks after DaRT insertion. ]
    Assessment of the reduction in tumor volume SUVmax based on CT/PET - CT measured tumor volume.

  2. DaRT seeds placement [ Time Frame: Day of insertion. ]
    Assessment of the DaRT seed placement by localization of the DaRT seed in the tumor using CT imaging.

  3. Change in quality of life: EORTC-QLQ-C30 [ Time Frame: Day 0, 30, 70, 6 months (+/-14 days). ]
    Assessment of patient reported health-related Quality of Life (QoL) outcomes after DaRT treatment, using QoL questionnaires EORTC-QLQ-C30. Scale range in score from 0 (best) to 100(worst).

  4. Progression free survival [ Time Frame: 6 months (+/-14 days). ]
    Time elapsed from response to disease progression.

  5. Pathological remissions. [ Time Frame: 12 weeks after DaRT seed insertion. ]
    Assessment of (complete) pathological remissions using histopathology examination

  6. Abscopal effects. [ Time Frame: 9-11 weeks after DaRT insertion. ]
    Assessment of abscopal effects on existing distant metastases based on PET-CT measured tumor volume.

  7. Change in quality of life: BR23 [ Time Frame: Day 0, 30, 70, 6 months (+/-14 days). ]
    Assessment of patient reported health-related Quality of Life (QoL) outcomes after DaRT treatment, using QoL questionnaires BR23. Scale range in score from 0 (best) to 100(worst).

  8. Abscopal effects [ Time Frame: 9-11 weeks after DaRT insertion. ]
    Assessment of abscopal effects on existing distant metastases based on PET-CT measured SUVmax decrease compared to the primary measurement (the baseline measurement).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970967


Contacts
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Contact: Naama Barel +972-3-618-24770 Naamab@alphatau.com
Contact: Aleksandr Obukhov, Dr. obuxov_al@mail.ru

Locations
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Russian Federation
A. Tsyb Medical Radiological Research Center Recruiting
Obninsk, Kaluga Region, Russian Federation, 249036
Contact: Aleksandr Obukhov, MD    +9264837984    obuxov_al@mail.ru   
Contact: Natalia B. Borysheva, PhD    +79109109899    borysheva@yandex.ru   
Sponsors and Collaborators
Alpha Tau Medical LTD.
Investigators
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Principal Investigator: Aleksandr Obukhov A. Tsyb Medical Radiological Research Centre, (A. Tsyb MRRC), Obninsk, Russia
More Information
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Responsible Party: Alpha Tau Medical LTD.
ClinicalTrials.gov Identifier: NCT03970967    
Other Study ID Numbers: CTP-BRST-01
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alpha Tau Medical LTD.:
Breast carcinoma
Metastatic breast cancer
Invasive breast cancer
Alpha radiation
Luminal A
 Luminal B
Triple negative
HER2
Breast cancer
Breast metastases
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes