Using dapagliflozin to protect the heart in breast cancer patients receiving chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III clinical trial evaluates the effectiveness of dapagliflozin in preventing cardiac dysfunction in breast cancer patients undergoing anthracycline chemotherapy. The study is multicenter, randomized, double-blind, and placebo-controlled, comparing the effects of dapagliflozin against a placebo. Participants will be monitored for signs of cardiotoxicity during their treatment. The goal is to determine if dapagliflozin can reduce the incidence of heart-related side effects associated with cancer treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• 4th Military Clinical Hospital with Polyclinic
  Wroclaw, Lower Silesian Voivodeship, Poland Recruiting
• Lower Silesian Centre for Oncology, Lung Diseases and Hematology
  Wroclaw, Lower Silesian Voivodeship, Poland Recruiting
• Military Medical Institute
  Warsaw, Masovian Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Waldemar Banasiak, PhD, MD — 4th Military Clinical Hospital with Polyclinic
• Study coordinator: Bartosz Krakowiak, PhD, MD
• Email: bkrakowiak@4wsk.pl
• Phone: +48 261 660 234

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.