Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

APRILIAH (Aprogen Phase III Clinical Trial to Compare Efficacy, Safety, and Immunogenicity of AP063 in Subjects with HER2+ Breast Cancer)

The APRILIAH study is a major clinical trial for women who have HER2-positive breast cancer. This type of breast cancer has a protein called HER2, which can make the cancer grow faster. Researchers are testing a new medicine, called AP063, to see if it's effective and safe. They want to find out if it can help women with breast cancer that has spread (metastatic) or with breast cancer that has been caught early. This study is in its final stages of testing, meaning a lot of research has already been done on this medicine. The goal is to see if this new treatment could be a good option for improving care.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Aprogen Inc.

Enrolment target

Start

08 Mar 2024

HER2-positive metastatic breast cancer (MBC) and early breast cancer (EBC)

What is this study about?

The APRILIAH study is a significant research project focusing on HER2-positive breast cancer. This is a specific type of breast cancer where the cells have too much of a protein called HER2. This protein helps cancer cells grow and spread, so treatments often target HER2 to slow down or stop the cancer.

This study is testing a new medicine called AP063. The main aim is to carefully compare AP063 with current treatments to understand if it's better, or just as good, at treating HER2-positive breast cancer. Researchers will be looking at how well the medicine works (its 'efficacy'), if it causes any unwanted side effects (its 'safety'), and how the body responds to it (its 'immunogenicity'). This involves finding out if the body's immune system reacts to the medicine in a particular way.

The study is looking at two groups of women: those with 'metastatic breast cancer' (meaning the cancer has spread to other parts of the body) and those with 'early breast cancer' (meaning the cancer hasn't spread far yet). By studying both groups, researchers can get a full picture of how AP063 might help patients at different stages of their illness. This kind of detailed research is crucial for developing new and better ways to treat cancer.

Key takeaways

This study tests a new medicine (AP063) for HER2-positive breast cancer.
It's for women aged 18 and over, with either advanced or early-stage HER2-positive breast cancer.
It compares AP063 to existing treatments for safety and effectiveness.
Participation involves regular hospital visits for treatment and check-ups.
You can stop participating at any time if you change your mind.

Who may be eligible?

This study is specifically for women who are 18 years old or older. There is no upper age limit, meaning older women are also welcome to take part.

To be considered for the study, you must have been diagnosed with HER2-positive breast cancer. This includes women whose breast cancer has spread to other parts of the body (called metastatic breast cancer) or women whose breast cancer has been found early (called early breast cancer).

The research team will have other specific medical rules about who can join to make sure the study is safe and that results are clear. These will involve looking at your overall health, any other medical conditions you might have, and any other treatments you are currently receiving. They will discuss all these details with you or your doctor.

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?
Are you 18 years old or older?
Have you been diagnosed with HER2-positive breast cancer?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the APRILIAH study, you would receive the new medicine being tested, AP063, or a standard treatment, depending on which group you are assigned to. This would involve regular visits to the hospital or clinic for treatments, check-ups, and tests like blood samples or scans. These visits help the doctors monitor how you are responding to the treatment and check for any side effects.

The study also involves regular follow-up appointments over a period of time to keep track of your health and how the treatment has affected your cancer in the longer term. The total duration of your participation, including treatment and follow-up, would be fully explained to you before you agree to join. You would be given a detailed schedule of all appointments and what each visit would involve.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as receiving a new medicine that might be more effective than current treatments for your HER2-positive breast cancer. You'll also receive close medical attention and monitoring throughout the study. However, there are also potential risks, as with any new medicine. AP063, like other cancer treatments, may have side effects, which the study will carefully track. It’s important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Poland
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Unverified
Romania

Common questions

What is HER2-positive breast cancer?

It's a type of breast cancer where cells have too much of a protein called HER2, which helps the cancer grow. Treatments often target this protein.

Is AP063 a new medicine?

Yes, AP063 is a new medicine being tested. This study is in the final stages of research, but it's not yet approved for general use.

Will I get the new medicine or a standard one?

You might receive the new medicine or a standard treatment. Which one you get is usually decided by chance, like flipping a coin, to make the study fair.

Can men join this study?

No, this specific study is only looking for women participants at this time.

What does 'Phase III' mean for a study?

Phase III means it's a large, final stage of testing. The treatment has already been studied in smaller groups and shown some promise, so now they're confirming its effects.