Clinical trial · Interventional
Alpha Radiation Emitters Device for the Treatment of Newly Diagnosed Breast Carcinoma Patients With Distant Metastases
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Newly Diagnosed Breast Carcinoma Patients With Distant Metastases
NCT03970967CI-TRIAL-00073096terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty in recruiting patients
Summary
Brief summary (as posted)
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for newly Diagnosed Breast Carcinoma patients with distant metastases
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Distant Metastases.Pathology | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DaRT Seeds
- description
- Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
- interventionNames
- Device: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Primary outcomes (2)
- measure
- Tumor response to DaRT
- timeFrame
- 9-11 weeks post DaRT insertion.
- description
- Assessment of the rate of malignant breast tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).
- measure
- Adverse Events
- timeFrame
- Day 0 - 6 months (+/-14 days)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.