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Heart shield? common diabetes drug tested to prevent chemo damage in breast cancer

NCT ID NCT06427226

Disease control 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 study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether dapagliflozin, a drug used for diabetes, can prevent heart damage caused by the chemotherapy drug doxorubicin in breast cancer patients. Researchers will enroll 46 women with early-stage breast cancer who are about to start chemotherapy. Participants will take dapagliflozin daily during their treatment cycles, and doctors will monitor heart function using echocardiograms and blood tests to see if the drug helps maintain a healthy heart.

What this could mean

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

Active substance
dapagliflozin (a diabetes drug repurposed to protect the heart)
What this could lead to
If it works, this could offer a simple way to protect breast cancer patients' hearts during chemotherapy, reducing the risk of long-term heart problems.
What could go wrong
This is a small, early-phase trial with only 46 participants, so results may not apply to everyone. Dapagliflozin may not prevent heart damage, and side effects like dehydration or infection are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 46 people

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

Started

Oct 2024

Expected to finish

Oct 2026

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 to 65 years

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: * Age ≥18 years old. * Chemo-naïve patients with biopsy confirmed diagnosis of breast cancer and with stage I-III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer). * Patients intended to receive at least 4 cycles of doxorubicin or more. * Patients with performance status \<2 according to Eastern Cooperative Oncology Group (ECOG) score. * Echocardiographic LVEF ≥55%. * Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 ×109/L, platelet count ≥ 90 × 109/L and hemoglobin level ≥ 10 g/dl). * Patients with adequate liver function and adequate renal function. * Signed informed consent to participate in the study. Exclusion Criteria: * Age \<18 years old and \>65 years old. * Patients with prior exposure to anthracyclines within the last 6 months. * Patients with evidence of metastasis at initial assessment. * Treatment with any SGLT-2 inhibitors for 6 months prior to the screening. * Patients taking any other cardioprotective medications. * Pregnancy and breast feeding. * Alcohol abuse. * History of heart failure or LVEF \<50%. * Presence of any cardiac-related conditions such as angina pectoris, valvular disease, uncontrolled systemic hypertension, coronary heart disease, and cardiac surgery within the last 3 months. * Patients with type 1 diabetes mellitus or diabetic ketoacidosis, history of stroke, and patients with severe renal impairment with GFR \<25ml/min/1.73m2 . - Patients taking gatifloxacin as it causes major drug interaction with dapagliflozin.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm doxorubicin induced cardiomyopathy prevention target

As listed by the trial registrant

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

Breast cancer Doxorubicin induced cardiomyopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medical Research Institute

    RECRUITING

    Alexandria, Bab Sharqi, 21526, Egypt

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