Cardioprotective Effect of Empagliflozin in Breast Cancer Patients

NCT07815808 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: DeltaU
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Empgliflozin Cardioprotective Effect

Keywords

Empagliflozin; Cardioprotection; Dox Cardiotoxicity

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (3)

Arm A (Control)

NO INTERVENTION

Standard oncologic care without cardioprotective intervention followed concurrently for 12 weeks

Arm B (Empaglflozin)

ACTIVE COMPARATOR

Empagliflozin 10 mg orally once daily initiated 1 week prior to chemotherapy; continued for 12 weeks

Drug: Empagliflozin (EMPA)

Arm C (Metformin)

ACTIVE COMPARATOR

Metformin 500 mg orally twice daily (escalated to 1000 mg twice daily as tolerated) initiated 1 week prior to chemotherapy; continued for 12 weeks

Drug: Metformin

Interventions

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.

Arm B (Empaglflozin)

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

Arm C (Metformin)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Written informed consent provided

You may not qualify if:

• 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.
• History of recurrent Urinary Tract Infections (UTIs), genital mycotic infections, or ketoacidosis (for Empagliflozin safety).
• Hypersensitivity to Empagliflozin or Metformin.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Elgharbeya, GHR, Egypt

Location

Related Publications (1)

• Gulgun M, Fidanci K, Genc FA, Kesik V. Natriuretic peptide and cardiac troponin levels in doxorubicin-induced cardiotoxicity. Anatol J Cardiol. 2016 Apr;16(4):299. doi: 10.14744/AnatolJCardiol.2016.7001. No abstract available.

  PMID: 27111202 BACKGROUND

MeSH Terms

Interventions

empagliflozin; Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Mohamed Abdelhamid Almeldein, Professor

  Tanta University

  STUDY DIRECTOR

• Mohamed Abdelhamid Alameldein, Professor

  Tanta University

  STUDY DIRECTOR

Central Study Contacts

Mai Aboelyazed El-Gebaly, Associate Lecturer

CONTACT

+0201061412257; dr.mai.elgebaly@gmail.com

Mai Aboelyazed Elgebaly, Associate Lecturer

CONTACT

+201115064114; dr.mai.elgebaly@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Lecturer

Model Details: Prospective, randomized, parallel-group, active-controlled trial.

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)