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:
NCT07137793
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years old.
* Chemo-naïve patients with biopsy confirmed diagnosis of breast cancer and with stage I-III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).
* Patients intended to receive at least 4 cycles of doxorubicin or more.
* Patients with performance status \<2 according to Eastern Cooperative Oncology Group (ECOG) score.
* Echocardiographic LVEF ≥55%.
* Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 ×109/L, platelet count ≥ 90 × 109/L and hemoglobin level ≥ 10 g/dl).
* Patients with adequate liver function and adequate renal function.
* Signed informed consent to participate in the study.
Exclusion Criteria:
* Age \<18 years old and \>65 years old.
* Women with history of breast cancer.
* Formerly treated with DOX.
* Patients with a known hypersensitivity to any of the used drugs.
* Treatment with blood thinners for 6 months prior to the screening.
* Treatment with NSAIDS like ketorolac,ibuprofen.
* Patients taking any other cardioprotective medications.
* Pregnancy and breast feeding.
* Alcohol abuse.
* Creatine Clearance \< 50 mL/min.
* History of heart failure or LVEF \<50%.
* Presence of any cardiac-related conditions such as angina pectoris, valvular disease, uncontrolled systemic hypertension, coronary heart disease, and cardiac surgery within the last 3 months.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07137793
Study Brief:
Protocol Section:
NCT07137793