Clinical trial NCT03970967: 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
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Alpha Tau Medical LTD.
Sponsor class: INDUSTRY
First posted: 2019-06-03
Enrollment: 1
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Tumor response to DaRT
timeFrame: 9-11 weeks post DaRT insertion.
measure: Adverse Events
timeFrame: Day 0 - 6 months (+/-14 days)
Secondary outcomes:
measure: Change in tumor volume.
timeFrame: 9-11 weeks after DaRT insertion.
measure: DaRT seeds placement
timeFrame: Day of insertion.
measure: Change in quality of life: EORTC-QLQ-C30
timeFrame: Day 0, 30, 70, 6 months (+/-14 days).
measure: Progression free survival
timeFrame: 6 months (+/-14 days).
measure: Pathological remissions.
timeFrame: 12 weeks after DaRT seed insertion.
measure: Abscopal effects.
timeFrame: 9-11 weeks after DaRT insertion.
measure: Change in quality of life: BR23
timeFrame: Day 0, 30, 70, 6 months (+/-14 days).
measure: Abscopal effects
timeFrame: 9-11 weeks after DaRT insertion.
Other outcomes:
Locations:
city: Obninsk
country: Russian Federation
facility: A. Tsyb Medical Radiological Research Center
state: Kaluga Region
Study officials:
affiliation: A. Tsyb Medical Radiological Research Centre, (A. Tsyb MRRC), Obninsk, Russia
name: Aleksandr Obukhov
role: PRINCIPAL_INVESTIGATOR
References: