Tests dapagliflozin to protect the heart during breast cancer chemotherapy
Tests dapagliflozin against placebo in adults with breast cancer receiving anthracycline chemotherapy.
Plain-language title generated from the registry record
Registry title: CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL
Key facts
- Where
- Warsaw and Wroclaw, PolandSee the 3 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06304857, who can take part
Where in Poland
- Military Medical InstituteWarsaw, PolandTaking people
- 4th Military Clinical Hospital with PolyclinicWroclaw, PolandTaking people
- Lower Silesian Centre for Oncology, Lung Diseases and HematologyWroclaw, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- 4th Military Clinical Hospital with Polyclinic, Poland
- Trial code
- NCT06304857EU 2023-506631-15-00
- Record updated
- 4 December 2024
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Urinary tract infection with the need for treatment with an antibiotic 48 hours before the scheduled start of anthracycline treatment; 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; Recognised heart failure or symptoms which, in the opinion of the investigator may be a symptom of undiagnosed heart failure; 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; Pulmonary hypertension; Life expectancy < 12 months or cancer disease stage IV according to the TNM classification; 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; Left ventricular ejection fraction < 50% at the time of the screening; Diagnosed type 1 or type 2 diabetes or fasting glucose ≥ 126 mg/dl or HbA1C ≥ 6,5% (48 mmol/mol); eGFR < 25 ml/min/1.73m2 according to CKD EPI; Alanine transaminase or aspartate transaminase levels above 2.5 times the local norm; Anemia with Hemoglobin < 9 g/dl; Cardiomyopathy: congenital, post-inflammatory, toxic, infiltrative (e.g. amyloidosis, sarcoidosis, haemochromatosis), postnatal or hypertrophic; Uncontrolled arterial pressure or systolic pressure < 80 mmHg at screening (at the discretion of the investigator); BMI > 40 kg/m2; Pregnancy or breastfeeding; Lack of compliance to use highly effective method of birth control; Taking semaglutide, liraglutide and metformin during the 30 days preceding the screening visit.