Dapagliflozin to prevent heart damage from anthracycline chemotherapy

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

Adults with breast cancer who are scheduled for adjuvant or neoadjuvant anthracycline chemotherapy will take dapagliflozin daily during their treatment while a comparator group receives standard care. Cardiac magnetic resonance spectroscopy, imaging of heart function, and blood biomarkers will be used to quantify myocardial energetic deficits and detect cardiotoxicity. The trial enrolls patients aged 18–70 with low to medium cardiovascular risk who can give written informed consent and read English. Primary outcomes focus on rates of cardiac dysfunction and changes in myocardial energetics over the chemotherapy period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with breast cancer between 18-70 years of age.
* Patients with low to medium cardiovascular risk.
* Patients scheduled for adjuvant or neo-adjuvant anthracycline therapy.
* Patients who are able to give written informed consent to take part in the study.
* Patients who can read and understand English.

The current thresholds for defining cardiovascular risk for patients undergoing anthracycline chemotherapy are as follows: normal resting 12-lead electrocardiogram, plasma cardiac troponin I concentration \< 99th centile, serum brain natriuretic peptide concentration \<35 pg/mL or serum N-terminal pro-brain natriuretic peptide concentration \<125 pg/mL, left ventricular ejection fraction \>55%, global longitudinal strain \>-18% and healthy life-style (normal body-mass index, non-smoker). Low cardiovascular risk will allow for the presence of one abnormal life-style factor (body-mass index indicating obesity (\>30 kg/m2), current smoker or significant smoking history), or presence of only one of the following in the clinical history: hypertension, stage 1-2 chronic kidney disease, age 65-79 years, borderline left ventricular ejection fraction (50-54%) or elevated cardiac biomarkers. Medium cardiovascular risk will permit the combination of any 2-4 of the lifestyle or clinical history variables indicated above.

Exclusion Criteria:

* Patients with a known intolerance of dapagliflozin
* Patients with high cardiovascular risk as specified by the most recent cardio-oncology guidelines.
* Patients with significant renal impairment (estimated glomerular filtration rate \<45 mL/min/1.73 m2).
* Patients with a previous cancer diagnosis.
* Patients with known type 1 or 2 diabetes mellitus. We will not actively screen for diabetes. This is not done in clinical practice and there have been no issues.
* Patients with a contraindication to magnetic resonance imaging.
* Patients with prior exposure to anthracyclines.
* Patients who cannot read and understand English.
* Patients who are pregnant

Where it's running

• Cardiac Research Office, Aberdeen Royal Infirmary
  Aberdeen, Aberdeenshire, United Kingdom Recruiting
• University of Aberdeen
  Aberdeen, United Kingdom Recruiting

Study contacts

• Principal investigator: Dana Dawson, MPhil — University of Aberdeen
• Study coordinator: Sylvia Kamya, MBChB
• Email: sylvia.kamya@nhs.scot
• Phone: +441224559573

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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.