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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* A history of clinically significant arrhythmia, including atrial fibrillation regardless of type (at discretion of the investigator).
* A history of stroke.
* Cardiomyopathy: congenital, post-inflammatory, toxic, infiltrative (e.g. amyloidosis, sarcoidosis, haemochromatosis), postnatal or hypertrophic.
* Pulmonary hypertension.
* Uncontrolled arterial pressure or systolic pressure \< 80 mmHg at screening (at the discretion of the investigator).
* BMI \> 40 kg/m2.
* Diagnosed type 1 or type 2 diabetes or fasting glucose ≥ 126 mg/dl or HbA1C ≥ 6,5% (48 mmol/mol).
* Pregnancy or breastfeeding.
* Lack of compliance to use highly effective method of birth control.
* Expected or possible treatment with epirubicin or liposomal doxorubicin within 12 months.
* Taking another study drug or drugs from the group of SGLT2 inhibitors up to 6 months before the screening visit.
* Taking semaglutide, liraglutide and metformin during the 30 days preceding the screening visit.
* eGFR \< 25 ml/min/1.73m2 according to CKD EPI.
* Life expectancy \< 12 months or cancer disease stage IV according to the TNM classification.
* Alanine transaminase or aspartate transaminase levels above 2.5 times the local norm.
* Anemia with Hemoglobin \< 9 g/dl.
* Kidney failure \> G2 (according to KDIGO classification).
* Liver disorders, Child-Pugh score \> 4.
* Known, active infections with HIV, HBV, HCV, tuberculosis.
* Any other condition which, in the opinion of the investigator, makes it impossible to fulfill the requirements for participation in this study.
Primary outcome measure(s)
Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 12 months. — 12 months Incidence of cancer therapeutics related cardiac dysfunction defined as:
1. the appearance of heart failure symptoms (NYHA class I-IV) due to an impairment of heart function or structure within 12 months; or
2. asymptomatic decrease in left ventricular ejection fraction \> 10% after 12 months; or
3. asymptomatic decrease in left ventricular ejection fraction \< 10% but up to 40-49% after 12 months; or
4. asymptomatic decrease in global left ventricular longitudinal strain \>15% after 12 months; or
5. asymptomatic increase in biomarkers (troponin I \> upper reference limit (99th centile) and increase of at least 30% from pre-treatment concentration or NTproBNP \> 125 pg/ml and increase of at least 30% from baseline) after 12 months.
Trial sites (3)
Facility
City
Region
Status
4th Military Clinical Hospital with Polyclinic
Wroclaw
Lower Silesian Voivodeship
Recruiting
Lower Silesian Centre for Oncology, Lung Diseases and Hematology
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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