CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
Sponsor4th Military Clinical Hospital with Polyclinic, Poland

About this trial

The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of cancer therapeutics-related cardiac dysfunction in patients with breast cancer receiving anthracycline treatment.

Eligibility criteria

Qualifiers

Age > 18 years and < 80 years.

Diagnosis of invasive breast cancer [stage I-III] and planned anthracycline treatment within 60 days.

Signed Informed Consent to participate in the study.

Disqualifiers

Urinary tract infection with the need for treatment with an antibiotic 48 hours before the scheduled start of anthracycline treatment.

Recognised heart failure or symptoms which, in the opinion of the investigator may be a symptom of undiagnosed heart failure.

Left ventricular ejection fraction < 50% at the time of the screening.

Severe valvular heart disease.

Trial design

Treatments tested in this trial

  • Dapagliflozin
  • Placebo

Treatment groups

188 Participants
are divided into 2 treatment groups