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Dapagliflozin for prevention of heart damage in women with breast cancer receiving anthracycline chemotherapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on women with Breast cancer who receive anthracycline chemotherapy, a powerful type of cancer medicine that can affect the heart. The investigation compares a daily tablet of dapagliflozin with a matching placebo to determine whether the active drug can protect the heart’s pumping ability, known as left ventricular systolic function, and the health of blood vessels, called vascular function. The purpose of the study is to see if adding the drug to standard care reduces damage to these heart and vessel functions.

Participants will take the assigned tablet for about a year while undergoing their regular cancer treatment. During this time they will have several non‑invasive heart checks, such as measurements of left ventricular global longitudinal strain (a way to see how the heart muscle moves), brachial flow-mediated dilation (how well an arm artery widens), and left ventricular ejection fraction (the percentage of blood the heart pumps out). Additional tests will look at the heart’s effort (myocardial work), the stiffness of arteries using carotid pulse wave velocity, and physical fitness measured by a 6-minute walk distance. Blood samples will be taken to check markers such as serum NT-proBNP (a sign of heart stress) and high-sensitivity troponin I (a sign of heart injury), as well as inflammatory substances like IL-6, galectin-3, and GDF-15. Quality‑of‑life questionnaires including EQ-5D, KCCQ, and SF-36 will also be completed.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Visit

    You will attend a first visit after enrollment. During this visit, the study team will record your medical history, perform a heart ultrasound (echocardiogram) to measure left ventricular function, and take blood samples for baseline biomarkers. You will also complete health questionnaires.

    You will be randomly assigned to receive either dapagliflozin 10 mg film‑coated tablet or a placebo tablet that looks the same. You will be instructed to take one tablet by mouth each day, starting on the day of this visit.

  2. Step 2

    Daily Medication

    Every day, you will swallow one tablet with water, preferably at the same time each day. The tablet contains either dapagliflozin 10 mg or an inactive lactose tablet (placebo). You will continue this daily regimen for the entire study period, up to 52 weeks, unless the study doctor advises otherwise.

  3. Step 3

    Anthracycline Chemotherapy

    You will receive your standard cancer treatment, which includes anthracycline chemotherapy. This chemotherapy is given in several cycles over several weeks. The study medication (dapagliflozin or placebo) is taken during the whole chemotherapy period.

    The chemotherapy may be given intravenously in a clinic or hospital. Your oncology team will manage the schedule and monitor side effects.

  4. Step 4

    Early Follow‑up After Two Chemotherapy Cycles

    After you have completed two cycles of chemotherapy, you will return for a follow‑up visit. At this visit, the study team will repeat the heart ultrasound, perform a blood test to measure markers such as NT‑proBNP and high‑sensitivity troponin I, and assess vascular function using a test called flow‑mediated dilation (FMD). These measurements help determine whether the heart is being protected.

    You will also be asked about any symptoms you have experienced and to complete the same health questionnaires as at baseline.

  5. Step 5

    Completion of Chemotherapy

    When you finish all scheduled chemotherapy cycles, you will have a visit that marks the end of the cancer‑treatment phase. The same heart and blood assessments performed at earlier visits will be repeated. This visit also confirms that you have taken the study medication for the intended duration.

  6. Step 6

    24‑Week Assessment

    Approximately 24 weeks after the baseline visit, you will attend a mid‑study assessment. This includes an echocardiogram to measure left ventricular ejection fraction and global longitudinal strain, a vascular test (flow‑mediated dilation), blood tests for cardiac biomarkers, a 6‑minute walk test to evaluate exercise capacity, and completion of quality‑of‑life questionnaires (EQ‑5D, KCCQ, SF‑36).

    The study team will compare these results with your baseline values to see how your heart and overall health have changed.

  7. Step 7

    52‑Week Assessment

    At about 52 weeks after the baseline visit, you will have the final study visit. All the assessments performed at the 24‑week visit are repeated: heart ultrasound, vascular test, blood biomarkers, 6‑minute walk test, and questionnaires.

    The final results will be used to determine whether dapagliflozin helped protect your heart compared with the placebo.

Who can join the trial?

3 criteria

  • Woman who is at least 18 years old.
  • Has breast cancer and is scheduled to receive a type of chemotherapy called anthracycline chemotherapy. This means four treatment cycles that include medicines named epirubicin or doxorubicin together with cyclophosphamide. The treatment will be given at the Institute of Oncology Ljubljana. (Anthracycline chemotherapy uses strong drugs to kill cancer cells; epirubicin and doxorubicin are similar drugs; cyclophosphamide is another cancer‑killing drug; “neo‑adjuvant” means the treatment is given before surgery to shrink the tumor.)
  • Willing to sign a written informed consent, which is a document that shows you understand the study and agree to take part.

Who cannot join the trial?

12 criteria

  • If you have known heart failure (the heart cannot pump blood well enough).
  • If you are known to be allergic (hypersensitivity) to SGLT2 inhibitors (a type of diabetes medicine).
  • If you have taken any SGLT2 inhibitor medication within the past 3 months.
  • If you are pregnant or breastfeeding (carrying a baby or feeding a baby with your milk).
  • If you have significant valvular disease (problems with the heart valves that control blood flow).
  • If you have had chemotherapy before or radiation treatment to the left side of the chest.
  • If you have type 1 diabetes (a form of diabetes where the body makes little or no insulin).
  • If you have symptomatic hypotension (low blood pressure that causes symptoms such as dizziness).
  • If you have frequent (recurrent) urinary tract infections.
  • If you have a history of ketoacidosis (a dangerous condition where the body builds up acids called ketones).
  • If you have hepatic impairment (liver problems) defined as liver enzymes ALT, AST, or ALP more than three times the normal upper limit.
  • If you have renal impairment (kidney problems) defined as eGFR less than 20 mL/min/1.73 m² (a measure of kidney function).
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Investigated drugs

Dapagliflozin is a medication that helps control blood sugar and has protective effects on the heart and blood vessels. In this trial, it is given in addition to the usual care for women with breast cancer who are receiving anthracycline chemotherapy. The purpose of adding dapagliflozin is to see if it can prevent or reduce the damage that chemotherapy can cause to the heart’s pumping ability and to the blood vessels, over a period of 26 to 52 weeks.

What is already known about the treatment

Forxiga 10 mg film-coated tablets - This medicine comes as a small, film‑coated tablet that is swallowed whole (oral administration). Dapagliflozin is already approved and widely used for type‑2 diabetes, heart failure, and chronic kidney disease, and many studies describe its benefits. It works by blocking a protein called SGLT2 in the kidneys, which stops the body from re‑absorbing sugar and causes a gentle loss of water, helping the heart and kidneys work better. Pharmacologically, it belongs to the class of SGLT2 inhibitors, also known as gliflozins.

Investigated diseases

  • Breast cancer

    A malignant tumor that originates in the cells of the breast. It can grow locally, invade surrounding tissues, and spread to nearby lymph nodes. Over time it may disseminate to distant organs such as bone, lung, or liver. The disease often progresses from an early stage to more advanced stages if not controlled.

  • Anthracycline-induced cardiotoxicity

    Damage to the heart muscle caused by anthracycline chemotherapy. The injury typically begins with subtle changes in the heart’s pumping ability. These changes can gradually worsen, leading to a measurable decline in left‑ventricular function. If the process continues, it may result in reduced ejection fraction and signs of heart failure.

Trial detailsLast updated 31 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-525705-13-00Protocol codeALPACAEstimated enrolment100 patientsSponsorInstitute Of Oncology Ljubljana

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