Cardioprotective Effect of Empagliflozin in Breast Cancer Patients

ConditionEmpgliflozin Cardioprotective Effect

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexFemale

Age18+

SponsorTanta University

About this trial

Background: Doxorubicin (DOX) remains a cornerstone in adjuvant and neoadjuvant therapy for breast cancer, but its utility is hindered by dose-dependent cardiotoxicity. Both SGLT2 inhibitors (Empagliflozin) and Biguanides (Metformin) have demonstrated off-target cardioprotective and metabolic properties in preclinical and clinical settings.

Objective: To compare the cardioprotective efficacy, safety, and metabolic/oncologic outcomes of Empagliflozin versus Metformin in non-diabetic or controlled-diabetic women with breast cancer undergoing doxorubicin-based chemotherapy.

Design: Prospective, 3-arm, open-label (or double-blind), randomized controlled clinical trial (RCT).

Duration: 18 months

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult females (≥18 years) with histologically confirmed breast cancer.

Scheduled to receive doxorubicin-based chemotherapy regimens (e.g., AC regimen: Doxorubicin + Cyclophosphamide every 2 or 3 weeks for 4 cycles).

Baseline LVEF ≥ 55 on transthoracic echocardiography with normal baseline GLS.

Estimated Glomerular Filtration Rate (eGFR) < 45 mL/min/1.73 m2

Disqualifiers

Prior exposure to anthracyclines, mediastinal radiation, or anti-HER2 therapy.

Pre-existing heart failure, coronary artery disease, or LVEF $< 55\%$.

Uncontrolled Type 2 Diabetes Mellitus (HbA1c $> 8.5\%$) or Type 1 Diabetes Mellitus.

Severe renal impairmet (eGFR < 45 mL/min/1.73 m2) or hepatic dysfunction.

Trial design

Design model

Parallel

Treatments tested in this trial

Empagliflozin (EMPA)
Drug
Intervention group: A group in which patients receive Empagliflozin drug at a dose of 10 mg once in the day, or along with chemotherapy.
Metformin
Drug
Metformin 500 mg orally twice daily (escalated to 1000 mg twice daily as tolerated) Initiated 1 week prior to chemotherapy; continued for 12 weeks

Treatment groups

150 Participants

are divided into 3 treatment groups

Group A: Arm A (Control)No intervention 0 interventions

Group B: Arm B (Empaglflozin)Active comparator 1 intervention

Group C: Arm C (Metformin)Active comparator 1 intervention

Trial outcomes

Primary outcomes

LVEF (Left ventricular ejection fraction) : The left ventricular drain fraction or the amount of blood pumped from the left ventricle with each contraction.

LVEF from baseline (T0) to 6-month follow-up (T3), measured by 2D Speckle-Tracking Echocardiography.

Time frame

6 months

Sponsors and contacts

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

Tanta University

Lead sponsor

Source ClinicalTrials.gov

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