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Two diabetes drugs face off to shield hearts during breast cancer chemo

NCT ID NCT07815808

Prevention Sponsor: Tanta University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Doxorubicin is a common chemotherapy for breast cancer, but it can damage the heart. This trial compares two diabetes drugs, empagliflozin and metformin, to see if either can protect heart function in women receiving doxorubicin-based treatment. About 150 women with breast cancer will be randomly assigned to receive one of the drugs or standard care, and researchers will track heart pumping ability over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
empagliflozin and metformin
What this could lead to
If either drug protects the heart during chemotherapy, it could become a routine add-on for women receiving doxorubicin, reducing heart damage without compromising cancer treatment.
What could go wrong
The trial may show no meaningful difference in heart function between the two drugs or standard care. Both drugs can cause side effects, and results in this group may not apply to all chemotherapy patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Empgliflozin cardioprotective effect

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Tanta University

    Tanta, Elgharbeya, GHR, Egypt

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