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Study on Sacubitril and Valsartan to Prevent Heart Damage in Breast Cancer Patients Undergoing Treatment

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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 prevention of heart damage during breast cancer treatment. The study is particularly interested in preventing heart failure, which can occur after treatment with certain cancer drugs known as anthracyclines. The treatment being tested is a medication called Entresto, which contains two active substances: valsartan and sacubitril. These substances work together to help protect the heart. The study will compare the effects of Entresto with a placebo, which looks like the real medication but does not contain any active ingredients.

The purpose of the study is to see if taking Entresto can prevent heart damage, specifically a decrease in the heart's ability to pump blood, during breast cancer treatment. Participants in the study will be randomly assigned to receive either Entresto or a placebo. The study will last for 24 months, during which time participants will have regular check-ups and heart scans to monitor their heart health. These scans will include an ultrasound of the heart, which uses sound waves to create images of the heart's structure and function.

Throughout the study, researchers will look for any changes in heart function, such as a decrease in the heart's pumping ability, and will also monitor for any other heart-related issues. The goal is to determine if Entresto can effectively prevent heart damage in patients undergoing breast cancer treatment, potentially improving their overall health and quality of life during and after their cancer treatment.

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, you will be randomly assigned to receive either the medication or a placebo. A placebo is a substance with no active medication, used to compare effects.
You will not know whether you are receiving the actual medication or the placebo, as this is a double-blind study. This means neither you nor the researchers will know which one you are receiving.
Step 2
Medication administration
If you are assigned to the medication group, you will take Entresto tablets. These tablets contain two active substances: valsartan and sacubitril.
The dosage will be either 49 mg/51 mg or 97 mg/103 mg, taken orally. The exact dosage and frequency will be determined by the study protocol and your healthcare provider.
Step 3
Regular check-ups
Throughout the study, you will have regular check-ups to monitor your heart health. This includes ultrasound scans to measure your heart's function.
These check-ups are important to ensure your safety and to assess the effectiveness of the treatment in preventing heart damage during breast cancer treatment.
Step 4
Monitoring and assessments
You will undergo various assessments, including magnetic resonance imaging (MRI) to check for any decrease in heart function.
Blood tests may also be conducted to measure levels of certain markers that indicate heart health.
Step 5
Completion of the study
The study will last for approximately 24 months from the time you start. During this period, your health and any changes in your heart function will be closely monitored.
At the end of the study, the results will be analyzed to determine the effectiveness of the medication in preventing heart damage.

Who can join the trial?

10 criteria

Provide written informed consent, which means you agree to participate after being informed about the study.
Have a sinus rhythm, which is a normal heartbeat pattern.
Be a female aged 18 years or older.
Have a diagnosis of breast cancer confirmed by a tissue sample test, with a complete assessment of the tumor's characteristics (ER, PR, HER2, Ki67).
Be able to take oral medication and be willing to follow the treatment plan.
Have a tumor grade of IA-IIIC or a limited spread of grade IV cancer, known as oligometastatic.
Have a treatment plan that includes surgery or treatment after surgery.
Plan to receive systemic treatment (treatment affecting the whole body) with anthracyclines and/or anti-HER2 drugs, either before or after surgery, or both.
Have an ECOG status of 0-2, which is a measure of your general health and ability to perform daily activities.
Have a left ventricular ejection fraction (LVEF) of 50% or higher, as measured by an ultrasound of the heart. This is a measure of how well your heart is pumping blood.

Who cannot join the trial?

3 criteria

Patients with a history of heart failure caused by a specific type of medication known as anthracyclines cannot participate. Anthracyclines are drugs used in cancer treatment that can sometimes affect the heart.
Only female patients are eligible to participate in this study.
Patients who are part of a vulnerable population are not eligible. This means individuals who might need special protection or care, such as those with certain disabilities or conditions, are excluded.

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Verified sites

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Medical University Of Gdansk
Gdansk, Poland
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Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Cracow, Poland

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Investigated drugs

Sacubitril/Valsartan is a medication used in this clinical trial to see if it can help protect the heart from damage caused by certain breast cancer treatments. Some cancer treatments can affect the heart's ability to pump blood effectively. This medication is a combination of two drugs that work together to help relax blood vessels and reduce the workload on the heart. By doing this, it may help prevent a decrease in the heart's pumping ability, which is a common side effect of some cancer therapies. The trial aims to find out if taking this medication can keep the heart healthier during and after cancer treatment.

What is already known about the treatment

Sacubitril/Valsartan – This medication is taken orally in the form of tablets and is used to help prevent heart problems in patients undergoing breast cancer treatment. It is currently being studied to see if it can stop heart damage caused by certain cancer drugs. The main use of Sacubitril/Valsartan is to prevent heart failure, especially in cases where the heart is weakened by cancer treatments. It works by blocking certain proteins in the body that can cause blood vessels to tighten, which helps to lower blood pressure and reduce stress on the heart. This medication is classified as an angiotensin receptor-neprilysin inhibitor (ARNI), which means it helps the heart work more efficiently by relaxing blood vessels and reducing fluid buildup.

Investigated diseases

Heart failure – post-anthracycline cardiomyopathy – This condition occurs when the heart muscle is damaged due to anthracycline chemotherapy, a treatment commonly used for cancer. The damage leads to a weakened heart muscle, which affects the heart's ability to pump blood effectively. Over time, this can result in symptoms such as fatigue, shortness of breath, and fluid retention. The progression of the disease may involve a gradual decline in heart function, often measured by a decrease in the left ventricular ejection fraction. As the heart's pumping ability diminishes, the body may struggle to meet its circulatory demands, leading to further complications. Monitoring and managing the condition is crucial to prevent worsening of heart function.