Empgliflozin Cardioprotective EffectPhase 3NCT07815808
Cardioprotective Effect of Empagliflozin in Breast Cancer Patients
A Phase 3 study testing Empagliflozin (EMPA) and Metformin in people with Empgliflozin Cardioprotective Effect, run by Tanta University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Empgliflozin Cardioprotective Effect
- What is being tested?
- Empagliflozin (EMPA) and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mai Aboelyazed El-Gebaly, Associate Lecturer contact
Egypt1 site
Tanta University
Tanta, Elgharbeya, GHR
Mai Aboelyazed El-Gebaly, Associate Lecturer, 010-6141-2257 ext. 020, dr.mai.elgebaly@gmail.com
Mai Aboelyazed Elgebaly, Associate Lecturer, 011-1506-4114 ext. 020, dr.mai.elgebaly@gmail.com
About this study
Official title: Effects of Empagliflozin Versus Metformin in Women With Breast Cancer Receiving Doxorubicin-Based Chemotherapy: A Prospective Randomized Controlled Cardio-Oncology 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
Read the detailed description
- Background \& Rationale Anthracyclines, primarily Doxorubicin, induce cardiotoxicity through reactive oxygen species (ROS) accumulation, topoisomerase II-beta inhibition, mitochondrial dysfunction, and cardiomyocyte apoptosis.
- Empagliflozin (SGLT2 inhibitor): Reduces oxidative stress, attenuates cardiac inflammation, improves myocardial energy bioenergetics, and prevents adverse left ventricular remodeling independently of glycemic status.
- Metformin (AMPK activator): Restores autophagic flux, preserves mitochondrial membrane potential, reduces ROS production, and exhibits anti-tumor proliferation effects.
- Gaps in Knowledge: While both drugs individually show promise against anthracycline-induced cardiotoxicity (AIC), direct head-to-head clinical trials comparing an SGLT2i versus Metformin during active anthracycline treatment are lacking.
- Study Hypothesis
- Primary Hypothesis: Prophylactic administration of Empagliflozin or Metformin significantly attenuates the subclinical decline in Left Ventricular Ejection Fraction (LVEF) and Global Longitudinal Strain (GLS) compared to standard care in women receiving doxorubicin.
- Secondary Hypothesis: Empagliflozin demonstrates superior reduction in cardiac biomarker elevation (hs-cTnI, NT-proBNP) and microvascular strain compared to Metformin.
- Study Objectives Primary Objective To compare the changes in left ventricular systolic function (measured via baseline to 6-month Echocardiographic GLS and LVEF) among the Empagliflozin group, Metformin group, and Control group.
Secondary Objectives
- Evaluate subclinical myocardial injury via serum biomarkers: High-sensitivity Cardiac Troponin I (hs-cTnI) and N-terminal pro-B-type Natriuretic Peptide (NT-proBNP).
- Monitor metabolic profiles (fasting blood glucose, HbA1c, and lipid profile).
- Evaluate patient-reported outcomes (Karnofsky Performance Scale / Minnesota Living with Heart Failure Questionnaire).
- Compare the safety profile, chemotherapy completion rates, and short-term oncologic response (pathological Complete Response in neoadjuvant settings).
- Methodology \& Study Design 5.1 Study Settings and Design
- Design: Prospective, randomized, parallel-group, active-controlled trial.
- Setting: Tanta Oncology Hospital / Cardio
- Conditions
- Empgliflozin Cardioprotective Effect
- Being tested
- Empagliflozin (EMPA), Metformin
- Keywords
- Empagliflozin, Cardioprotection, Dox Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
MetforminDrug
Metformin 500 mg orally twice daily (escalated to 1000 mg twice daily as tolerated) Initiated 1 week prior to chemotherapy; continued for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Empgliflozin Cardioprotective EffectStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, parallel-group, active-controlled trial.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Abo Elyazeed Hassan Hamouda, Tanta University
- Investigators
- Mohamed Abdelhamid Almeldein, Professor, Study director, Tanta UniversityMohamed Abdelhamid Alameldein, Professor, Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815808
- Sponsor's protocol ID
- DeltaU
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27111202
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Empagliflozin Versus Metformin in Women With Breast Cancer Receiving Doxorubicin-Based Chemotherapy: A Prospective Randomized Controlled Cardio-Oncology Trial
- ClinicalTrials.gov ID
- NCT07815808
- Acronym / sponsor ID
- DeltaU
- Conditions
- Empgliflozin Cardioprotective Effect
- Keywords
- Empagliflozin, Cardioprotection, Dox Cardiotoxicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- Background \& Rationale Anthracyclines, primarily Doxorubicin, induce cardiotoxicity through reactive oxygen species (ROS) accumulation, topoisomerase II-beta inhibition, mitochondrial dysfunction, and cardiomyocyte apoptosis.
- Empagliflozin (SGLT2 inhibitor): Reduces oxidative stress, attenuates cardiac inflammation, improves myocardial energy bioenergetics, and prevents adverse left ventricular remodeling independently of glycemic status.
- Metformin (AMPK activator): Restores autophagic flux, preserves mitochondrial membrane potential, reduces ROS production, and exhibits anti-tumor proliferation effects.
- Gaps in Knowledge: While both drugs individually show promise against anthracycline-induced cardiotoxicity (AIC), direct head-to-head clinical trials comparing an SGLT2i versus Metformin during active anthracycline treatment are lacking.
- Study Hypothesis
- Primary Hypothesis: Prophylactic administration of Empagliflozin or Metformin significantly attenuates the subclinical decline in Left Ventricular Ejection Fraction (LVEF) and Global Longitudinal Strain (GLS) compared to standard care in women receiving doxorubicin.
- Secondary Hypothesis: Empagliflozin demonstrates superior reduction in cardiac biomarker elevation (hs-cTnI, NT-proBNP) and microvascular strain compared to Metformin.
- Study Objectives Primary Objective To compare the changes in left ventricular systolic function (measured via baseline to 6-month Echocardiographic GLS and LVEF) among the Empagliflozin group, Metformin group, and Control group.
Secondary Objectives
- Evaluate subclinical myocardial injury via serum biomarkers: High-sensitivity Cardiac Troponin I (hs-cTnI) and N-terminal pro-B-type Natriuretic Peptide (NT-proBNP).
- Monitor metabolic profiles (fasting blood glucose, HbA1c, and lipid profile).
- Evaluate patient-reported outcomes (Karnofsky Performance Scale / Minnesota Living with Heart Failure Questionnaire).
- Compare the safety profile, chemotherapy completion rates, and short-term oncologic response (pathological Complete Response in neoadjuvant settings).
- Methodology \& Study Design 5.1 Study Settings and Design
- Design: Prospective, randomized, parallel-group, active-controlled trial.
- Setting: Tanta Oncology Hospital / Cardio
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective, randomized, parallel-group, active-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Arm A (Control) | No intervention | –Standard oncologic care without cardioprotective intervention followed concurrently for 12 weeks |
| Arm B (Empaglflozin) | Active comparator | Drug: Empagliflozin (EMPA)Empagliflozin 10 mg orally once daily initiated 1 week prior to chemotherapy; continued for 12 weeks |
| Arm C (Metformin) | Active comparator | Drug: MetforminMetformin 500 mg orally twice daily (escalated to 1000 mg twice daily as tolerated) initiated 1 week prior to chemotherapy; continued for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin (EMPA)Intervention group: A group in which patients receive Empagliflozin drug at a dose of 10 mg once in the day, or along with chemotherapy. | Drug | Arm B (Empaglflozin) |
| MetforminMetformin 500 mg orally twice daily (escalated to 1000 mg twice daily as tolerated) Initiated 1 week prior to chemotherapy; continued for 12 weeks | Drug | Arm C (Metformin) |
Primary outcome
LVEF (Left ventricular ejection fraction) : The left ventricular drain fraction or the amount of blood pumped from the left ventricle with each contraction.
Time frame: 6 months
LVEF from baseline (T0) to 6-month follow-up (T3), measured by 2D Speckle-Tracking Echocardiography.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 27111202Gulgun 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mai Aboelyazed El-Gebaly, Associate Lecturer contact
Mohamed Abdelhamid Almeldein, Professor study director
Tanta University
Mohamed Abdelhamid Alameldein, Professor study director
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Empagliflozin (EMPA) and Metformin in people with Empgliflozin Cardioprotective Effect, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mai Aboelyazed El-Gebaly, Associate Lecturer (+0201061412257 ext. 020, dr.mai.elgebaly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LVEF (Left ventricular ejection fraction) : The left ventricular drain fraction or the amount of blood pumped from the left ventricle with each contraction. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07815808, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.