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

Primary Purpose

Breast Carcinoma, Metastatic Breast Cancer, Invasive Breast Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Breast Carcinoma focused on measuring Breast carcinoma, Metastatic breast cancer, Invasive breast cancer, Alpha radiation, Luminal A, Luminal B, Triple negative, HER2, Breast cancer, Breast metastases

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

A. Tsyb Medical Radiological Research CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DaRT Seeds

Arm Description

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Outcomes

Primary Outcome Measures

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).

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

Secondary Outcome Measures

Change in tumor volume.

Assessment of the reduction in tumor volume SUVmax based on CT/PET - CT measured tumor volume.

DaRT seeds placement

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

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 elapsed from response to disease progression.

Pathological remissions.

Assessment of (complete) pathological remissions using histopathology examination

Abscopal effects.

Assessment of abscopal effects on existing distant metastases based on PET-CT measured tumor volume.

Change in quality of life: BR23

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

Assessment of abscopal effects on existing distant metastases based on PET-CT measured SUVmax decrease compared to the primary measurement (the baseline measurement).

Full Information

NCT ID

NCT03970967

First Posted

May 23, 2019

Last Updated

February 16, 2022

Sponsor

Alpha Tau Medical LTD.

1. Study Identification

Unique Protocol Identification Number

NCT03970967

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 28, 2019 (Actual)

Primary Completion Date

August 2026 (Anticipated)

Study Completion Date

October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alpha Tau Medical LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DaRT Seeds

Arm Type

Experimental

Arm Description

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Tumor response to DaRT

Description

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

Time Frame

9-11 weeks post DaRT insertion.

Title

Adverse Events

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in tumor volume.

Description

Assessment of the reduction in tumor volume SUVmax based on CT/PET - CT measured tumor volume.

Time Frame

9-11 weeks after DaRT insertion.

Title

DaRT seeds placement

Description

Assessment of the DaRT seed placement by localization of the DaRT seed in the tumor using CT imaging.

Time Frame

Day of insertion.

Title

Change in quality of life: EORTC-QLQ-C30

Description

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).

Time Frame

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

Title

Progression free survival

Description

Time elapsed from response to disease progression.

Time Frame

6 months (+/-14 days).

Title

Pathological remissions.

Description

Assessment of (complete) pathological remissions using histopathology examination

Time Frame

12 weeks after DaRT seed insertion.

Title

Abscopal effects.

Description

Assessment of abscopal effects on existing distant metastases based on PET-CT measured tumor volume.

Time Frame

9-11 weeks after DaRT insertion.

Title

Change in quality of life: BR23

Description

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).

Time Frame

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

Title

Abscopal effects

Description

Assessment of abscopal effects on existing distant metastases based on PET-CT measured SUVmax decrease compared to the primary measurement (the baseline measurement).

Time Frame

9-11 weeks after DaRT insertion.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Naama Barel

Phone

+972-3-618-24770

Naamab@alphatau.com

First Name & Middle Initial & Last Name or Official Title & Degree

Aleksandr Obukhov, Dr.

obuxov_al@mail.ru

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aleksandr Obukhov

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

A. Tsyb Medical Radiological Research Center

City

Obninsk

State/Province

Kaluga Region

ZIP/Postal Code

249036

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aleksandr Obukhov, MD

Phone

+9264837984

obuxov_al@mail.ru

First Name & Middle Initial & Last Name & Degree

Natalia B. Borysheva, PhD

Phone

+79109109899

borysheva@yandex.ru

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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