Active not recruitingOBSERVATIONAL

Evaluation of Myocardial Changes During BReast Adenocarcinoma Therapy to Detect Cardiotoxicity Earlier With MRI

Some breast cancer treatments, while life-saving, can sometimes affect the heart. This study is looking at women with a specific type of breast cancer (HER2-positive) who are receiving a combination of treatments including anthracyclines and trastuzumab. Researchers want to see if using a special type of MRI scan can detect early changes in the heart muscle, like increased water levels, that might lead to heart problems later on. By spotting these signs early, doctors hope to find ways to give heart-protective medicines sooner, potentially preventing serious heart conditions. The study is divided into two parts, and the first part has already finished enrolling participants.

At a glance

Status

Active not recruiting

Sponsor

University Health Network, Toronto

Enrolment target

180

Start

01 Oct 2013

Estimated completion

01 Jan 2027

Breast Neoplasms

What is this study about?

For Canadian women, breast cancer is the most common type of cancer. About 15-20% of these early breast cancers have high levels of a protein called HER2. While this type of cancer can be more aggressive, certain treatments, combining medications like anthracyclines and trastuzumab (which targets HER2), have greatly improved survival.

However, these powerful treatments can sometimes put a strain on the heart. In some cases, this can lead to heart muscle damage, and in a smaller number of patients, it can cause heart failure. Once heart failure develops, it can significantly affect a person's lifespan and quality of life. This study is exploring a way to get ahead of these heart problems.

Researchers believe that if they can detect early signs of heart strain after the anthracycline treatment, they might be able to start heart-protective medications sooner. They are particularly interested in whether an increase in water levels in the heart muscle, which can be seen with a special type of MRI scan, is an early warning sign. By using advanced MRI techniques, the study hopes to identify patients who are at higher risk of developing heart problems and ultimately find better ways to keep their hearts healthy while they fight cancer.

Key takeaways

Aims to find early signs of heart strain during breast cancer treatment.
Uses special MRI scans to look for changes in the heart.
Focuses on women receiving specific breast cancer drugs (anthracyclines and trastuzumab).
Hopes to help doctors prevent serious heart problems in the future.
Participation involves several MRI scans over 15 months.

Who may be eligible?

This study is looking for women who are planning to start specific treatments for breast cancer. These treatments typically involve a combination of drugs such as 5-fluorouracil, epirubicin, cyclophosphamide, and often include docetaxel and trastuzumab. You would need to be well enough to have about five MRI scans over roughly 15 months and be able to understand and agree to take part in the study.

There are also some reasons why you wouldn't be able to join. For example, if your doctor thinks your life expectancy is less than a year, or if you're already trying a new cancer drug in another study. Also, if you've had certain heart problems before, like a heart attack or previous heart failure, or have severe kidney issues, this study might not be right for you. If you have anything that makes MRI scans unsafe for you, you also wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman diagnosed with breast cancer?
Are you scheduled for specific breast cancer treatments (e.g., anthracyclines followed by trastuzumab)?
Are you able to have about five MRI scans over 15 months?
Do you have good kidney function?
Do you not have a history of serious heart problems like heart attack or heart failure?

Answer every question to see your result.

What does participation involve?

If you join this study, you would undergo several heart MRI scans. You'll have one scan before you start your breast cancer treatment, another after you finish a part of your treatment called anthracyclines, a third scan while you are receiving trastuzumab, and a final scan at the very end of all your treatment. In total, you would have about five MRI scans over a period of about 15 months. Each scan will last around 60 minutes. Apart from the MRI scans, your cancer treatment would continue as planned by your doctors.

Potential risks and benefits

Taking part in this study may help doctors learn how to better protect the hearts of future breast cancer patients. While there isn't a direct benefit to your health from participating, the information gained could lead to improved care for others. The main risks are those associated with MRI scans, such as lying still for prolonged periods. There are no injections of new or experimental drugs. Remember, you can choose to leave the study at any time without it affecting your usual medical care.

Locations (1)

Toronto General Hospital
Verified postcode
Toronto, Canada

Common questions

What is HER2-positive breast cancer?

It's a type of breast cancer that has a lot of a protein called HER2, which can make the cancer grow faster.

What are anthracyclines and trastuzumab?

They are types of powerful medicines used to treat breast cancer, especially HER2-positive types.

What is a cardiac MRI?

It's a special scan that uses magnets and radio waves to create detailed pictures of your heart, without using X-rays.

What does 'heart dysfunction' mean?

It means the heart isn't pumping as strongly or efficiently as it should be.

Will this study change my cancer treatment?

No, your cancer treatment will continue as planned by your doctors; this study is just adding extra heart monitoring.