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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT04800393
Eligibility Criteria:
Inclusion Criteria:
* The age of the patients is from 45 to 74 years;
* Primary operable breast cancer (BC) without prior chemotherapy;
* Cytologically confirmed breast malignant tumor of IA-IIA stages (T1-2, N0, M0);
* Signed informed consent.
Exclusion Criteria:
* Acute cerebrovascular accident (CVA) occurred in the previous 6 months;
* Myocardial infarction (MI) occurred in the previous 6 months;
* Acute arterial thrombosis occurred in the previous 6 months;
* Acute venous thromboembolism occurred in the previous 6 months;
* Subarachnoid hemorrhage occurred during the previous 3 months;
* Chronic kidney disease (CKD) stage 3B-5;
* Сhronic heart failure (NYHA) class 3-4;
* Pregnancy;
* History of another location cancer;
* History of drug addiction;
* Autoimmune diseases in history;
* Post-randomization: withdrawal of informed consent (refusal to continue participating in the study);
* Post-randomization: surgical intervention, performed not in full (verified non-resected lesions in the early p/o period, 2 weeks p/o).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
74 Years
Study:
NCT04800393
Study Brief:
Protocol Section:
NCT04800393