AuthorisedTherapeutic exploratory (Phase II)Interventional

A multicentre, prospective, open-label study with [68Ga]Ga-ABY-025 PET-imaging to characterize HER2-expression and explore the therapy-predictive value for HER2-antibody drug conjugates in patients with metastatic breast cancer (HER2-Ex PET)

This research study is for people with breast cancer that has spread to other parts of the body. We are looking at a new type of scan called a PET scan using a special tracer ([68Ga]Ga-ABY-025). This scan helps us see the HER2 protein on cancer cells. The main goal is to find out if the results from this special scan can predict how well a targeted treatment, Enhertu, will work for patients. Enhertu is a drug designed to specifically target and kill cancer cells that have the HER2 protein. By understanding this, doctors hope to make better decisions about which treatments are most likely to help patients with advanced breast cancer. It's a Phase II study, meaning we're exploring how effective and safe this approach is.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Karolinska University Hospital

Enrolment target

Start

23 Dec 2024

Breast Cancer

What is this study about?

This study is about people who have breast cancer that has spread to other parts of their body, which doctors call metastatic breast cancer. We're particularly interested in breast cancers that have a protein called HER2 on their surface. This protein can make some cancers grow faster.

In this study, we're using a special type of body scan called a PET scan. This scan uses a unique marker ([68Ga]Ga-ABY-025) that attaches to the HER2 protein. This helps us see exactly where the HER2 protein is in the body and how much there is. The main aim is to see if what we find on this scan can help predict how well a specific cancer drug, called Enhertu, will work for patients. Enhertu is a modern treatment designed to target HER2-positive cancer cells.

By doing this, we hope to learn if this special scan can tell us early on whether Enhertu will be a good treatment choice for someone. This could lead to more personalised and effective treatment plans for people living with metastatic breast cancer in the future.

Key takeaways

This study uses a special scan to understand breast cancer better.
It's for women with breast cancer that has spread.
The study tests a targeted drug called Enhertu.
It aims to see if the scan can predict how well the treatment will work.
You would receive regular check-ups and scans.

Who may be eligible?

To join this study, people need to be at least 18 years old. The study is open to female patients only. You must have been diagnosed with breast cancer that has spread to other parts of your body, known as metastatic breast cancer.

Your doctors will need to check other health details and past treatments to make sure this study is safe and right for you. They will review all your medical information carefully to see if you meet all the specific requirements for taking part.

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 diagnosed with breast cancer that has spread?
Are you 18 years old or older?
Are you female?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have several visits to the hospital or clinic. You will have special PET scans before you start treatment with Enhertu, and then again after about 3-4 cycles of treatment. This is to see how the HER2 levels change. You will also have regular CT scans, blood tests, and physical examinations to monitor your health and how the treatment is working. You will receive Enhertu as an infusion (drip) in the hospital according to a set schedule. We will also ask you to fill out questionnaires about your quality of life, to understand how you are feeling during the study. The total duration of your participation will depend on how you respond to the treatment, with ongoing follow-up visits to monitor your progress.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that the treatment you receive (Enhertu) might help your cancer. Also, by participating, you will help researchers learn more about how to better treat breast cancer in the future. Potential risks could include side effects from the Enhertu treatment, or from the scans and tests involved, such as exposure to small amounts of radiation from the PET and CT scans. Your study doctor will discuss all known side effects and risks with you in detail. Remember, you can decide to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What is HER2-positive breast cancer?

HER2-positive breast cancer means the cancer cells have too much of a protein called HER2 on their surface, which can make them grow faster.

What is Enhertu?

Enhertu is a targeted drug specifically designed to treat HER2-positive breast cancer that has spread.

What is a PET scan and why is it used?

A PET scan is a special imaging test that uses a small amount of radioactive substance to help doctors see how your body's tissues and organs are working, in this case, to identify HER2 levels in cancer.

Will this study cure my cancer?

This study aims to find more effective ways to treat metastatic breast cancer and improve understanding of the disease, but it cannot guarantee a cure.

What happens if the treatment doesn't work for me?

Your doctors will regularly monitor your response. If the treatment isn't working or if you have severe side effects, they will discuss other treatment options with you.