Dapagliflozin to prevent chemotherapy-related heart damage in breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 trial enrolling adult women with breast cancer who will receive (neo)adjuvant anthracycline-based chemotherapy. Participants are randomized to dapagliflozin 10 mg daily or matching placebo started prior to or at the initiation of chemotherapy and followed through treatment and short-term follow-up. Cardiac function (LVEF, GLS, myocardial work), vascular measures (flow-mediated dilation and carotid stiffness), exercise capacity, and multiple cardiac injury and inflammation biomarkers will be measured at baseline and predefined intervals. The trial aims to determine whether dapagliflozin reduces early cardiac and vascular changes associated with anthracycline exposure.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Medical Centre Ljubljana
  Ljubljana, Slovenia Recruiting

Study contacts

• Study coordinator: Jure Tršan
• Email: jure.trsan@gmail.com
• Phone: Slovenia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.