Image

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

Recruiting
18 - 80 years of age
Both
Phase 3

Powered by AI

Overview

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.

Description

This is a multicentre, randomised, double-blind, placebo-controlled phase III study, evaluating the effect of dapagliflozin versus placebo on prevention of cardiotoxicity in breast cancer patients undergoing anthracycline-based chemotherapy.

Eligibility

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.

Study details

Breast Cancer, Heart Failure

NCT06304857

4th Military Clinical Hospital with Polyclinic, Poland

30 April 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.