RecruitingPhase 3NCT06304857

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

A Multicentre, Randomised, Double-blind, Placebo-controlled Phase III Study, Evaluating the Effect of Dapagliflozin on Prevention of Cardiotoxicity in Breast Cancer Patients Undergoing Anthracycline-based Chemotherapy

Sponsor

4th Military Clinical Hospital with Polyclinic, Poland

Enrollment

188 participants

Start Date

Apr 15, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Heart Failure

Summary

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

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 Criteria24

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.