JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year
This study is for patients with recently diagnosed HER2-positive breast cancer that needs targeted therapy called trastuzumab (Herceptin). This drug can sometimes affect heart function. Current guidelines require a heart scan (echocardiogram) every 3 months during treatment. The JUSTIFY study is testing whether a smarter, more personalized approach is just as safe. Rather than scanning everyone at the same frequency, patients would be scanned based on their individual risk of heart problems. The study aims to show that reducing unnecessary scans can lower patient stress and treatment burden, reduce interruptions to cancer treatment, and cut healthcare costs, all without compromising heart safety.
At a glance
What is this study about?
If you've been diagnosed with early-stage breast cancer that's HER2-positive (stage 1-3), your doctors might suggest a special type of treatment that targets the HER2 protein. While these treatments are very effective at fighting cancer, they can sometimes put a strain on your heart. Because of this, current guidelines mean you have regular heart checks, sometimes every three months, even if you feel completely fine and have no history of heart problems.
However, these guidelines for heart checks were put in place a long time ago, and recent research suggests that a lot of these tests don't actually change the patient's treatment plan. This means many people might be having tests they don't really need. This can be stressful, lead to delays in cancer treatment, and increase costs for the healthcare system. This study wants to see if there's a better, more personal way to manage these heart checks.
This study plans to involve 300 patients with HER2-positive breast cancer to try out a new, more tailored approach. Instead of everyone having tests every three months, patients will be assessed for their individual risk of heart problems. Those at lower risk might have tests every six months, while those at slightly higher risk might have them every four months. The researchers will compare this new plan to the usual way of doing things to see if fewer checks are just as safe and effective. They will look at heart health, whether patients can complete their cancer treatment, and how patients feel about having fewer tests. If successful, this new way of doing things could save money and make treatment less demanding for patients without putting their health at risk.
Key takeaways
- This study aims to reduce unnecessary heart checks for HER2-positive breast cancer patients.
- It tests a new way of checking heart health based on individual risk.
- The goal is to be just as safe as current care, with fewer tests.
- Could reduce patient stress, treatment delays, and healthcare costs.
- Participants will have heart tests every 4 or 6 months, instead of every 3 months.
Who may be eligible?
This study is looking for both men and women between the ages of 18 and 79. You must have early-stage breast cancer (stage 1 to 3) that is HER2-positive and you must be planning to have HER2-targeted therapy to cure your cancer.
There are certain reasons why you might not be able to join the study. For example, if your breast cancer has already spread to other parts of your body, you wouldn't be eligible. Also, if you have certain existing heart conditions, such as a history of heart attack, heart failure, severe heart valve problems, or a very fast and irregular heartbeat called atrial fibrillation, you wouldn't be able to take part.
Other reasons not to join include if your heart scans aren't clear enough to measure, or if you've already had a very high dose of a type of chemotherapy called anthracycline. You also wouldn't be eligible if you have significant symptoms of heart disease or are very limited in your daily activities due to your health.
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 between 18 and 79 years old?
- Do you have early-stage (Stage 1-3) HER2-positive breast cancer?
- Are you planning to receive HER2-targeted therapy for your cancer?
- Do you not have cancer that has spread to other parts of your body?
- Have you *not* had a past heart attack, heart failure, or severe heart valve problems?
- Is your current heart function (as measured by a doctor) generally normal?
- Have you had previous exposure to other cancer therapies?
What does participation involve?
The detailed information about what taking part involves is not fully described in this brief summary. However, based on the study's aim, if you join, you would be assigned to one of two groups: a 'low-risk' group or an 'intermediate-risk' group. Instead of the usual heart tests every three months, your heart health would be checked less frequently – either every 4 months (if you're in the intermediate-risk group) or every 6 months (if you're in the low-risk group) – for the first year of your HER2-targeted therapy. The study will monitor your heart health, how well you complete your cancer treatment, and your overall feelings about this new testing schedule. The total duration of the study's primary monitoring period appears to be the first year of treatment, but follow-up beyond that might occur.
Potential risks and benefits
Locations (2)
- Women's College HospitalVerified postcodeToronto, Canada
- Toronto General HospitalUnverifiedToronto, Canada
Common questions
What is HER2-positive breast cancer?
It's a type of breast cancer that has too much of a protein called HER2, which helps cancer cells grow. Special medicines are used to target this protein.
Why do these cancer treatments affect the heart?
While very good at fighting cancer, some HER2-targeted therapies can, in some people, make the heart muscle weaker. This is why doctors usually monitor heart health carefully.
What does 'low risk' or 'intermediate risk' mean?
This refers to your individual chance of developing heart problems during treatment. Doctors will look at your health history to decide which group you fit into.
Will my cancer treatment be affected by this study?
The study aims to see if you can complete your cancer treatment effectively while having fewer heart checks. Your cancer treatment itself will continue as planned by your doctors.
What kind of heart tests will I have?
The study mentions 'heart tests,' which typically involve scans like an echocardiogram (an ultrasound scan of the heart) to check its function.
What kind of commitment do I have to make for the study?From the study team
You will be asked to complete research questionnaires either online, over-the-phone, or in person. You will also be followed up with a study investigator to assess your heart health every three months for the duration of your participation.
What else do I need to know about the study intervention?From the study team
You may be randomized into the fewer imaging arm. However, during the follow-ups if your doctor feels there any reason for you receive an echocardiogram, additional tests may be ordered as needed.
What if I decide not to participate in the study?From the study team
Participation in the study is completely voluntary. If you choose not to participate in the study you will still need to get echocardiograms for the duration of your treatment every 3 months as per the standard of care.
How to find out more
JUSTIFY Research Team
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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