Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT06304857

CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL

Led by 4th Military Clinical Hospital with Polyclinic, Poland · Updated on 2024-12-04

188

Participants Needed

3

Research Sites

193 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • Urinary tract infection requiring antibiotic treatment within 48 hours before starting anthracycline treatment.
  • Known heart failure or symptoms suggestive of undiagnosed heart failure.
  • Left ventricular ejection fraction < 50% at screening.
  • Severe valvular heart disease.
  • History of significant arrhythmia, including atrial fibrillation.
  • History of stroke.
  • Cardiomyopathy of various types (congenital, post-inflammatory, toxic, infiltrative, postnatal, hypertrophic).
  • Pulmonary hypertension.
  • Uncontrolled arterial pressure or systolic pressure < 80 mmHg at screening.
  • Body mass index > 40 kg/m2.
  • Diagnosed type 1 or type 2 diabetes or fasting glucose ≥ 126 mg/dl or HbA1C ≥ 6.5%.
  • Pregnancy or breastfeeding.
  • Non-compliance with highly effective birth control methods.
  • Expected or possible treatment with epirubicin or liposomal doxorubicin within 12 months.
  • Use of SGLT2 inhibitors up to 6 months before screening.
  • Use of semaglutide, liraglutide, or metformin within 30 days before screening.
  • Estimated glomerular filtration rate < 25 ml/min/1.73m2.
  • Life expectancy less than 12 months or cancer stage IV.
  • Elevated liver enzymes above 2.5 times normal.
  • Anemia with hemoglobin < 9 g/dl.
  • Kidney failure worse than stage G2.
  • Liver disorders with Child-Pugh score > 4.
  • Active infections with HIV, HBV, HCV, or tuberculosis.
  • Any other condition making participation impossible, as judged by the investigator.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 3 locations

1

4th Military Clinical Hospital with Polyclinic

Wroclaw, Lower Silesian Voivodeship, Poland, 50-981

Actively Recruiting

2

Lower Silesian Centre for Oncology, Lung Diseases and Hematology

Wroclaw, Lower Silesian Voivodeship, Poland, 53-413

Actively Recruiting

3

Military Medical Institute

Warsaw, Masovian Voivodeship, Poland, 04-141

Actively Recruiting

Loading map...

Research Team

B

Bartosz Krakowiak, PhD, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here