Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase 2a Study of ZW25 in Combination with Palbociclib Plus Fulvestrant

This research study is investigating a new treatment approach for specific breast cancers that are advanced or have spread (metastatic). The conditions include HER2-positive and HR-positive breast cancer that can't be operated on or has spread. Researchers are combining a new drug called ZW25 with two established medications, palbociclib (IBRANCE) and fulvestrant (Faslodex). The main goal is to understand the safety of this new combination, looking at potential side effects and how patients tolerate the drugs. They also want to see how well the treatment helps control the cancer, such as slowing its growth. This is a Phase 2 study, meaning it's an early step to gather more information after initial safety tests.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Jazz Pharmaceuticals Ireland Limited

Enrolment target

Start

16 Sep 2024

Breast cancer patients including those with locally advanced (unresectable) or metastatic HER2-positive HR-positive breast cancer

What is this study about?

This study is exploring a new way to treat certain kinds of breast cancer that are either advanced (meaning they've grown quite a bit) or have spread to other parts of the body. Specifically, it's for cancer that is 'HER2-positive' and 'HR-positive'. These are features of the cancer cells that doctors look for when deciding on the best treatment. When we say 'advanced' or 'metastatic,' it means the cancer is more serious and may be harder to treat with surgery alone.

The researchers are combining three different medications. Two of these, palbociclib (often known by its brand name IBRANCE) and fulvestrant (Faslodex), are already used to treat breast cancer. The third, ZW25, is a new drug being tested. The idea is that using them together might be more effective than using them separately. By combining these treatments, doctors hope to find a powerful new option for patients.

This is called a 'Phase 2a' study. This means it's an earlier stage of research where doctors are mainly focusing on understanding the safety of the new combination. They'll carefully watch for any side effects and see how well patients tolerate the treatment. They will also start to look at how well the treatment works in slowing down or stopping the cancer's growth. The results from this study will help decide if this new combination should be tested in larger studies.

Key takeaways

This study is for advanced, HER2-positive and HR-positive breast cancer.
It tests a new drug (ZW25) in combination with two existing cancer medicines.
The main goals are to check the treatment's safety and early effectiveness.
It's a 'Phase 2a' study, an early step in testing new treatments.
Close medical monitoring is provided for all participants.
Joining is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or over. The study is open to both men and women.

Critically, you must have been diagnosed with a specific type of advanced breast cancer. This means your breast cancer needs to be 'HER2-positive' and 'HR-positive,' and it should either be locally advanced (can't be removed by surgery) or have spread to other parts of your body (metastatic).

There will be other detailed medical criteria that a study doctor will check to make sure the study treatment is suitable and safe for you. These might include your general health, other medical conditions you have, and any previous treatments you've received.

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 18 years old or older?
Do you have breast cancer?
Has your breast cancer been diagnosed as 'HER2-positive' and 'HR-positive'?
Is your breast cancer advanced (locally untreatable by surgery) or has it spread to other parts of your body?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study drugs: capsules of IBRANCE, injections of Faslodex, and another drug called ZW25 (the form of ZW25 isn't specified, but it could be capsules or an injection). You would have regular visits to the clinic for check-ups, where doctors and nurses will monitor your health very closely. This involves various assessments like blood tests, heart scans (ECG), and other tests to check your overall health and how the treatment is affecting you.

Special attention will be paid to any side effects you might experience. The study will track how often these happen and their severity. You'll also likely have scans to see how your cancer is responding to the treatment. The total duration of the study and how long you would receive treatment would be explained to you by the study team, but participation would involve regular, ongoing visits while you are on the treatment and potentially follow-up after you stop the drugs.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as gaining access to a new treatment before it's widely available and receiving very close medical monitoring from experts. However, there are also potential risks; the new drug ZW25 might have side effects that are not yet fully known, and even established drugs can cause side effects. The treatment might not work for everyone, or it could even make your condition worse. It's very important to remember that joining a study is always your choice, and you have the right to withdraw from 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
Spain

Common questions

What is HER2-positive and HR-positive breast cancer?

These are specific characteristics of breast cancer cells. HER2-positive means the cancer cells have too much of a protein called HER2, which helps them grow. HR-positive (Hormone Receptor-positive) means the cancer cells grow in response to hormones like oestrogen or progesterone. Doctors use these details to choose the best treatments.

What is a 'Phase 2a' study?

A Phase 2a study is an early stage of clinical research. It's mainly focused on finding out if a new treatment is safe and tolerable, and to get an early idea of whether it might work. If the results are promising, the treatment can move to larger studies.

Will I know if I'm getting the new drug or a standard treatment?

In this specific study, everyone receives the new drug ZW25 along with palbociclib and fulvestrant. It's not a study where some people get a placebo or a different standard treatment group, at least in the general design described.

What are 'side effects'?

Side effects are unwanted or unexpected reactions to a medicine. All medicines can have side effects. In this study, doctors will be carefully looking for and recording any side effects to understand the safety of the new combination.

How long will I be in the study?

The exact duration would be discussed with you by the research team. It typically involves receiving treatment for a period and then ongoing monitoring. Your individual situation and how you respond to the treatment would influence the length of your participation.