NCT06304857 CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL
| NCT ID | NCT06304857 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | 4th Military Clinical Hospital with Polyclinic, Poland |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 188 participants in total. It began in 2024-04-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Waldemar Banasiak, PhD, MD
PRINCIPAL INVESTIGATOR
4th Military Clinical Hospital with Polyclinic
Frequently Asked Questions
Who can join the NCT06304857 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06304857 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 188 participants.
Is NCT06304857 currently recruiting?
Yes, NCT06304857 is actively recruiting participants. Contact the research team at bkrakowiak@4wsk.pl for enrollment information.
Where is the NCT06304857 trial being conducted?
This trial is being conducted at Wroclaw, Poland, Wroclaw, Poland, Warsaw, Poland.
Who is sponsoring the NCT06304857 clinical trial?
NCT06304857 is sponsored by 4th Military Clinical Hospital with Polyclinic, Poland. The principal investigator is Waldemar Banasiak, PhD, MD at 4th Military Clinical Hospital with Polyclinic. The trial plans to enroll 188 participants.
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