Dapagliflozin for Heart Health in Breast Cancer Patients

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

Recruiting Phase 3 Interventional Study
Breast Cancer Heart Failure
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
188 (estimated)
Sponsor
4th Military Clinical Hospital with Polyclinic, Poland · Other
Who this trial is looking for

This trial is looking for breast cancer patients who will receive anthracycline treatment. Participants will take dapagliflozin to see how it affects heart health during cancer treatment.

Are You a Good Fit for This Trial?
Rules you out Severe valvular heart diseaseCongenital cardiomyopathyPulmonary hypertensionKidney failure G2Liver disordersActive infections with HIV or hepatitis

You may be able to join if

  • I am between 18 and 80 years old.
  • I have been diagnosed with invasive breast cancer.
  • I plan to start anthracycline treatment within 60 days.
  • I have signed consent to participate in the study.

You may not be able to join if

  • I have a urinary tract infection requiring antibiotics.
  • I have recognized heart failure or symptoms that suggest it.
  • My left ventricular ejection fraction is less than 50%.
  • I have severe heart valve disease.
  • I have a history of clinically significant arrhythmia.
  • I have had a stroke.
  • I am pregnant or breastfeeding.
  • I do not use effective birth control.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Answer a few quick questions to see if you may meet the eligibility requirements.

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About This Trial

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.

Trial Locations
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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…
Contacts

Bartosz Krakowiak, PhD, MD

+48 261 660 234

bkrakowiak@4wsk.pl

CONTACT