Cardiotoxicity in Breast Cancer Patients
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHelwan University
About this trial
The goal of this clinical trial is to learn if dapagliflozin drug has a cardioprotective effect against anthracyclines-induced cardiotoxicity. It will also learn about the safety of dapagliflozin drug.
Aim of the study:
Evaluate cardioprotective effect and safety of dapagliflozin against anthracyclines-induced cardiotoxicity.
The main questions it aims to answer are:
1. Does the drug lower the cardiotoxicity which induced by anthracyclines? 2. What medical problems do participants have when taking dapagliflozin drug?
Treatment
1. Anthracyclines by 4 cycles included doxorubicin 50-60 mg/m2 with cyclophosphamide 600 mg as a combination or epirubicin 90-100 mg/m2 with cyclophosphamide 600 mg as a combination. 2. Dapagliflozin 10 mg tablet orally, once daily. Started 7 days before the first cycle of anthracyclines till the end of last anthracyclines dose.
Eligibility criteria
Qualifiers
patients with pathologically proved invasive breast carcinoma.
Patients were indicated for anthracyclines containing adjuvant chemotherapy or new adjuvant anthracyclines.
Renal function (eGFR > 30 mL/minute per 1.73 m2 )
LVEF is more than 50 %
Disqualifiers
patients with any cardiac condition that contraindicate the use of anthracyclines, like heart failure, arrythmia, stroke and myocardial infarction.
Previous anthracycline-containing regimens and any cardiotoxic chemotherapy regimens
pregnant or breastfeeding patients
patients receiving any other cardiotoxic agents.
Trial design
Treatments tested in this trial
- Dapagliflozin 10mg Tab
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov