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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Dapagliflozin 10mg Tab
Drug
Dapagliflozin 10 mg tablet orally, once daily. Started 7 days before the first cycle of anthracyclines till the end of last anthracyclines dose. taken orally, once daily. Started from 5 to 7 days before the first cycle of anthracyclines till the end of last anthracycline dose.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Dapagliflozin groupActive comparator 1 intervention

Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

N-terminal pro-B-type natriuretic peptide (NT-pro BNP) testing

Monitoring the serum at Baseline and after the last cycle of anthracyclines. Changes in serum NT-Pro BNP from baseline will be calculated and compared between groups

Time frame

Baseline and after the last cycle of anthracyclines ( 0 and 2 to 3 months from baseline)

Secondary outcomes

Echocardiography by measuring left ventricular ejection fraction (LVEF)

LVEF (%) will be assessed using M-mode and 2D echocardiography performed by an experienced operator blinded to the patient's history. Changes in LVEF from baseline will be calculated and compared between groups at each time point.

Time frame

a) Baseline b) After the last cycle of anthracyclines (approximately 2 to 3 months from baseline) c) 3 months after the end of chemotherapy (approximately 5 to 6 months from baseline) d) As needed for any symptomatic patients

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helwan University

Lead sponsor

Source ClinicalTrials.gov

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