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出境医 / 临床实验 / Alpha Radiation Emitters Device for the Treatment of Newly Diagnosed Breast Carcinoma Patients With Distant Metastases

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

Study Description
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
Layout table for study information
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 2022
Estimated Study Completion Date : October 2023
Arms and Interventions
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
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
Layout table for eligibility information
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

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

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Aleksandr Obukhov A. Tsyb Medical Radiological Research Centre, (A. Tsyb MRRC), Obninsk, Russia
Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date January 13, 2021
Actual Study Start Date  ICMJE November 28, 2019
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • 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).
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • 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.
  • 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.
  • 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).
  • Progression free survival [ Time Frame: 6 months (+/-14 days). ]
    Time elapsed from response to disease progression.
  • Pathological remissions. [ Time Frame: 12 weeks after DaRT seed insertion. ]
    Assessment of (complete) pathological remissions using histopathology examination
  • 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.
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alpha Radiation Emitters Device for the Treatment of Newly Diagnosed Breast Carcinoma Patients With Distant Metastases
Official Title  ICMJE A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Newly Diagnosed Breast Carcinoma Patients With Distant Metastases
Brief Summary A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for newly Diagnosed Breast Carcinoma patients with distant metastases
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Carcinoma
  • Metastatic Breast Cancer
  • Invasive Breast Cancer
  • Distant Metastases.Pathology
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Intervention: Device: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Naama Barel +972-3-618-24770 Naamab@alphatau.com
Contact: Aleksandr Obukhov, Dr. obuxov_al@mail.ru
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03970967
Other Study ID Numbers  ICMJE CTP-BRST-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alpha Tau Medical LTD.
Study Sponsor  ICMJE Alpha Tau Medical LTD.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aleksandr Obukhov A. Tsyb Medical Radiological Research Centre, (A. Tsyb MRRC), Obninsk, Russia
PRS Account Alpha Tau Medical LTD.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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