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

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

This study is testing if the medication dapagliflozin can help protect the hearts of breast cancer patients who are receiving chemotherapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 188 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: 4th Military Clinical Hospital with Polyclinic, Poland (Academic / other)
• Drugs / interventions: doxorubicin, chemotherapy
• Locations: 3 sites (Wroclaw, Lower Silesian Voivodeship and 2 other locations)
• Trial ID: NCT06304857 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 80 with invasive breast cancer (stage I-III) who are scheduled to begin anthracycline treatment.

Not a fit: Patients with existing heart conditions or significant cardiac dysfunction will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of heart failure in breast cancer patients undergoing chemotherapy.

How similar studies have performed: Previous studies have shown promise in using similar approaches to mitigate cardiotoxicity in cancer treatments, but this specific application is novel.

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.

Where this trial is running

Wroclaw, Lower Silesian Voivodeship and 2 other locations

• 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

Conditions Breast Cancer; Heart Failure; breast cancer; heart failure; ejection fraction; anthracyclines