Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT03970967
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT03970967
Study Brief:
Protocol Section:
NCT03970967