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:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT07245069
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥18 years.
* Histologically confirmed breast cancer with planned (neo)adjuvant anthracycline-based chemotherapy (4 cycles of epirubicin + cyclophosphamide or doxorubicin + cyclophosphamide).
* Eligible to start dapagliflozin or placebo prior to or at initiation of chemotherapy.
* Able to perform baseline echocardiography, vascular ultrasound (FMD and carotid stiffness), 6-minute walk test, and biomarker sampling.
* Willing and able to provide written informed consent.
Exclusion Criteria:
* Known heart failure (any prior diagnosis of HF).
* Clinically significant valvular heart disease.
* Prior exposure to chemotherapy or radiotherapy to the left chest.
* Type 1 diabetes mellitus.
* Symptomatic hypotension.
* History of recurrent urinary tract infections.
* History of diabetic ketoacidosis or ketonemia.
* Severe hepatic impairment (ALT, AST, ALP \>3× upper limit of normal).
* Severe renal impairment (eGFR \<20 mL/min/1.73 m²).
* Known allergy or intolerance to SGLT-2 inhibitors.
* Any use of SGLT-2 inhibitor therapy within 3 months prior to enrollment.
* Pregnancy or breastfeeding.
* Any condition that, in the investigator's judgment, could interfere with study participation, safety, or completion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07245069
Study Brief:
Protocol Section:
NCT07245069