Not recruiting

Study on Dapagliflozin to Prevent Heart Damage in Breast Cancer Patients Receiving Anthracycline Chemotherapy

Fast replyRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Featured sites

Sites that work closely with us on this trial

Verified & featuredResponsive
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Warsaw, Poland
Not recruiting

What is this trial about?

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

This clinical trial is focused on studying the effects of the medication dapagliflozin on preventing heart damage in patients with breast cancer who are receiving a type of chemotherapy known as anthracycline-based chemotherapy. The study involves patients with invasive breast cancer at stages I to III who are scheduled to start this chemotherapy within 60 days. The medication being tested is called Forxiga, which contains dapagliflozin, and it is compared to a placebo, which looks like the real medication but does not contain the active ingredient.

The purpose of the study is to see if dapagliflozin can help prevent heart problems that might occur as a side effect of the chemotherapy. Participants in the study will be randomly assigned to receive either dapagliflozin or the placebo. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased. The study will last for 12 months, during which time the participants' heart health will be monitored to check for any signs of heart dysfunction, such as changes in heart function or structure, or changes in certain heart-related biomarkers.

Throughout the study, the participants' heart health will be assessed at different points, including at 6 and 12 months, to see if there are any changes in heart function or symptoms of heart failure. The study will also look at other health outcomes, such as changes in quality of life and any side effects that may occur. The goal is to determine if dapagliflozin can effectively reduce the risk of heart problems in breast cancer patients undergoing anthracycline-based chemotherapy.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on age (18-80 years) and diagnosis of invasive breast cancer at stage I-III. Anthracycline treatment must be planned within 60 days.
Informed consent is required to participate in the study.
Step 2
Randomization and medication
Participants are randomly assigned to receive either dapagliflozin or a placebo. The medication is administered orally in the form of a film-coated tablet.
The dosage is 10 mg of dapagliflozin or a placebo equivalent, taken once daily.
Step 3
Treatment duration
The treatment continues for a period of 12 months. Regular intake of the assigned medication is crucial throughout this period.
Step 4
Monitoring and assessments
Participants undergo regular monitoring to assess heart function and detect any signs of cardiac dysfunction.
Assessments include measuring heart failure symptoms, changes in heart function, and levels of specific biomarkers at 6 and 12 months.
Step 5
End of study evaluations
At the end of the 12-month period, a comprehensive evaluation is conducted to determine the effect of the treatment on heart health.
The primary focus is on the prevention of cardiac dysfunction related to cancer treatment.

Who can join the trial?

4 criteria

Must be between 18 and 80 years old.
Must have been diagnosed with invasive breast cancer at stages I to III. This means the cancer has spread into surrounding breast tissue but not to distant parts of the body.
Must have a plan to start anthracycline treatment within 60 days. Anthracycline is a type of chemotherapy used to treat cancer.
Must sign an Informed Consent form, which means agreeing to participate in the study after understanding all the details and risks involved.

Who cannot join the trial?

9 criteria

Patients who have a different type of cancer other than invasive breast cancer.
Patients who are not in stage I-III of breast cancer.
Patients who are not planning to receive anthracycline treatment within 60 days. Anthracycline treatment is a type of chemotherapy used to treat cancer.
Patients who are under 18 years old or over 65 years old.
Patients who are not willing to participate in the study for 12 months.
Patients who have a history of heart problems that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are currently participating in another clinical trial.
Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified & featuredResponsive
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Warsaw, Poland
Not recruiting
Verified
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu
Wroclaw, Poland
Verified
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Wroclaw, Poland

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Dapagliflozin is a medication being studied for its potential to prevent heart damage in breast cancer patients who are receiving a specific type of chemotherapy known as anthracycline-based chemotherapy. This medication is typically used to treat diabetes by helping the kidneys remove glucose from the bloodstream. In this trial, researchers are investigating whether it can also protect the heart from the harmful effects of chemotherapy.

Dapagliflozin

What is already known about the treatment

Dapagliflozin – Dapagliflozin is administered orally in tablet form. It is currently being studied in clinical trials to assess its potential in preventing heart damage in breast cancer patients receiving anthracycline-based chemotherapy. The main therapeutic indication being explored is the prevention of cardiac dysfunction related to cancer treatment. At the molecular level, dapagliflozin works by inhibiting a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2), which helps reduce blood sugar levels and may have protective effects on the heart. It is classified as an SGLT2 inhibitor, primarily used for managing type 2 diabetes, but its role in cardioprotection is under investigation.

Investigated diseases

Invasive Breast Cancer
This type of cancer begins in the breast tissue and has the potential to spread to surrounding tissues or other parts of the body. It is categorized into stages I to III, with each stage indicating the extent of cancer spread. Stage I is the earliest, where cancer is confined to the breast, while stage III indicates more extensive spread to nearby lymph nodes or tissues. The progression of invasive breast cancer can vary, with some cases growing slowly and others more rapidly. Treatment plans often depend on the stage and specific characteristics of the cancer. Regular monitoring and follow-up are crucial to manage the disease effectively.
Cancer Therapeutics-Related Cardiac Dysfunction (CTRCD)
This condition occurs as a side effect of certain cancer treatments, particularly those involving anthracyclines. It involves damage to the heart muscle, leading to impaired heart function. Symptoms may include heart failure signs, such as shortness of breath or fatigue, but it can also be asymptomatic with changes detected through imaging or biomarker tests. The dysfunction can manifest as a decrease in the heart's ability to pump blood effectively, often measured by a reduction in left ventricular ejection fraction. Monitoring heart function during and after cancer treatment is essential to detect and manage CTRCD. The condition's progression can vary, and early detection is key to preventing further cardiac complications.