Clinical trial · Interventional
Cardioprotective Effect of Empagliflozin in Breast Cancer Patients
Effects of Empagliflozin Versus Metformin in Women With Breast Cancer Receiving Doxorubicin-Based Chemotherapy: A Prospective Randomized Controlled Cardio-Oncology Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Empgliflozin Cardioprotective Effect | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Empagliflozin (EMPA) | Drug | — | UNRESOLVED |
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Arm A (Control)
- description
- Standard oncologic care without cardioprotective intervention followed concurrently for 12 weeks
- type
- ACTIVE_COMPARATOR
- label
- Arm B (Empaglflozin)
- description
- Empagliflozin 10 mg orally once daily initiated 1 week prior to chemotherapy; continued for 12 weeks
- interventionNames
- Drug: Empagliflozin (EMPA)
- type
- ACTIVE_COMPARATOR
- label
- Arm C (Metformin)
- description
- Metformin 500 mg orally twice daily (escalated to 1000 mg twice daily as tolerated) initiated 1 week prior to chemotherapy; continued for 12 weeks
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult females (≥18 years) with histologically confirmed breast cancer. 2. Scheduled to receive doxorubicin-based chemotherapy regimens (e.g., AC regimen: Doxorubicin + Cyclophosphamide every 2 or 3 weeks for 4 cycles). 3. Baseline LVEF ≥ 55 on transthoracic echocardiography with normal baseline GLS. 4. Estimated Glomerular Filtration Rate (eGFR) \< 45 mL/min/1.73 m2 5. Written informed consent provided Exclusion Criteria: 1. Prior exposure to anthracyclines, mediastinal radiation, or anti-HER2 therapy. 2. Pre-existing heart failure, coronary artery disease, or LVEF $\< 55\\%$. 3. Uncontrolled Type 2 Diabetes Mellitus (HbA1c $\> 8.5\\%$) or Type 1 Diabetes Mellitus. 4. Severe renal impairmet (eGFR \< 45 mL/min/1.73 m2) or hepatic dysfunction. 5. History of recurrent Urinary Tract Infections (UTIs), genital mycotic infections, or ketoacidosis (for Empagliflozin safety). 6. Hypersensitivity to Empagliflozin or Metformin.
References
Publications (1)
- BACKGROUNDGulgun 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