Recruiting
CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA 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.
ClinicalTrials.gov IDNCT06304857
PhasePHASE3
Enrollment188
Sponsor4th Military Clinical Hospital with Polyclinic, Poland
Age18 Years – 80 Years
SexALL
Conditions studied
Breast Cancer, Heart Failure
About this study
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.
Interventions
- Drug: Dapagliflozin — 10 mg tablet q.d
- Drug: Placebo — tablet matching dapagliflozin 10 mg q.d
Primary outcomes
- Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 12 months. (12 months)
Eligibility information
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.
Study locations
- 4th Military Clinical Hospital with Polyclinic, Wroclaw, Lower Silesian Voivodeship 50-981 Poland
- Lower Silesian Centre for Oncology, Lung Diseases and Hematology, Wroclaw, Lower Silesian Voivodeship 53-413 Poland
- Military Medical Institute, Warsaw, Masovian Voivodeship 04-141 Poland
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-19.