Breast CarcinomaNCT03970967
Alpha Radiation Emitters Device for the Treatment of Newly Diagnosed Breast Carcinoma Patients With Distant Metastases
A study testing Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Breast Carcinoma and Metastatic Breast Cancer, run by Alpha Tau Medical LTD. at 1 site in Russia.
Trial summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for newly Diagnosed Breast Carcinoma patients with distant metastases Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Breast Carcinoma, Metastatic Breast Cancer, Invasive Breast Cancer
- What is being tested?
- Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteRussia
- Study dates
- 28 Aug 2019to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
A. Tsyb Medical Radiological Research Center
Obninsk, Kaluga Oblast, 249036
About this study
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
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for newly Diagnosed Breast Carcinoma patients with distant metastases
Read the 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.
- Conditions
- Breast Carcinoma, Metastatic Breast Cancer, Invasive Breast Cancer, Distant Metastases.Pathology
- Being tested
- Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Keywords
- Breast carcinoma, Metastatic breast cancer, Invasive breast cancer, Alpha radiation, Luminal A, Luminal B, Triple negative, HER2, Breast cancer, Breast metastases
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| DaRT Seeds | Experimental | Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds Receives: Device: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: Day 0 - 6 months (+/-14 days)
Secondary outcomes (8)
Change in tumor volume.
Assessment of the reduction in tumor volume SUVmax based on CT/PET - CT measured tumor volume.
Measured: 9-11 weeks after DaRT insertion.
DaRT seeds placement
Assessment of the DaRT seed placement by localization of the DaRT seed in the tumor using CT imaging.
Measured: Day of insertion.
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).
Measured: Day 0, 30, 70, 6 months (+/-14 days).
Progression free survival
Time elapsed from response to disease progression.
Measured: 6 months (+/-14 days).
Pathological remissions.
Assessment of (complete) pathological remissions using histopathology examination
Measured: 12 weeks after DaRT seed insertion.
Abscopal effects.
Assessment of abscopal effects on existing distant metastases based on PET-CT measured tumor volume.
Measured: 9-11 weeks after DaRT insertion.
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).
Measured: Day 0, 30, 70, 6 months (+/-14 days).
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).
Measured: 9-11 weeks after DaRT insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start28 Aug 2019
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Why it stopped: Difficulty in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Alpha Tau Medical LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alpha Tau Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aleksandr Obukhov, Principal investigator, A. Tsyb Medical Radiological Research Centre, (A. Tsyb MRRC), Obninsk, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970967
- Sponsor's protocol ID
- CTP-BRST-01
- Status last verified
- Feb 2022
- First submitted
- 23 May 2019
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03970967
- Acronym / sponsor ID
- CTP-BRST-01
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting patients
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DaRT Seeds | Experimental | Device: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (15 listed)
- T4 category with skin involvement.
- Regional lymph node metastases.
- Ductal carcinoma in situ.
- Inflammatory breast carcinoma.
- Patients with pre-irradiation of the breast.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | DaRT Seeds |
Primary outcome
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
8 secondary outcomes
Change in tumor volume.
Time frame: 9-11 weeks after DaRT insertion.
DaRT seeds placement
Time frame: Day of insertion.
Change in quality of life: EORTC-QLQ-C30
Time frame: Day 0, 30, 70, 6 months (+/-14 days).
Progression free survival
Time frame: 6 months (+/-14 days).
Pathological remissions.
Time frame: 12 weeks after DaRT seed insertion.
Abscopal effects.
Time frame: 9-11 weeks after DaRT insertion.
Change in quality of life: BR23
Time frame: Day 0, 30, 70, 6 months (+/-14 days).
Abscopal effects
Time frame: 9-11 weeks after DaRT insertion.
Results and safety
The study was stopped early (reason given: Difficulty in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandr Obukhov principal investigator
A. Tsyb Medical Radiological Research Centre, (A. Tsyb MRRC), Obninsk, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Breast Carcinoma and Metastatic Breast Cancer, run by Alpha Tau Medical LTD. at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty in recruiting patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response to DaRT (time frame: 9-11 weeks post DaRT insertion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.