Ongoing, recruitingTherapeutic use (Phase IV)Interventional

FUnctional selection of advanced breast cancer patients for Talazoparib treatment Using the REpair Capacity (RECAP) test: The FUTURE trial

This study, called FUTURE, is for people with advanced breast cancer. Researchers want to see if a special test, called RECAP, can tell us whether a medicine called Talzenna (talazoparib) will be effective. Talzenna is a capsule taken by mouth. The main goal is to find out what percentage of patients, identified by the RECAP test, will have their breast cancer controlled (meaning it doesn't get worse) for at least four months while taking Talzenna. They will also look at how many people respond to the treatment and how long they live overall. This study aims to help doctors choose the best treatment for individual patients with breast cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

31 Jan 2025

Breast cancer

What is this study about?

This study is called the FUTURE trial, and it's looking into a new way to help people with advanced breast cancer. The main idea is to see if a special test, called RECAP, can help doctors understand which patients might benefit most from a specific medicine called Talzenna (talazoparib). Talzenna is a treatment that comes as a capsule you swallow.

The researchers want to find out if the RECAP test can predict how well Talzenna will work for you. Specifically, they'll be checking to see if, for people whose test results suggest it, the cancer stays stable or shrinks for at least four months while taking Talzenna. This is important because it could help doctors choose the right treatment for each patient more effectively, avoiding treatments that are less likely to work.

Besides looking at how long the cancer is kept under control, the study will also check other things like how many people's cancers shrink (this is called the overall response rate) and how long people live in total. They will also explore if the test can accurately show when the treatment might *not* be helpful for some patients. All of this information helps build a clearer picture of how Talzenna works and for whom.

Key takeaways

This study explores if a test can predict who benefits from a breast cancer drug.
The drug being tested is Talzenna (talazoparib) for advanced breast cancer.
The main goal is to see if the cancer is controlled for at least four months.
It helps doctors choose more effective individual treatments.
Open to adults aged 18 and over, both men and women.

Who may be eligible?

To join this study, you need to be at least 18 years old. There's no upper age limit, so people of all adult ages can take part.

This study is open to both men and women. Your doctor will need to check your specific health condition and medical history to make sure this study is right for you, as there are other criteria that aren't listed here.

It's important to talk to your healthcare team to understand if you meet all the requirements and if this trial is a suitable option for your unique situation.

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 advanced breast cancer?
Are you willing to take a capsule medication (Talzenna)?
Are you comfortable with regular clinic visits and tests?
Are you happy to be part of a research study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be taking medication called Talzenna, which comes as hard capsules. This is a Phase IV trial, meaning the drug has already been approved but researchers are gathering more information on its use. Your participation would involve regular visits to the clinic to monitor your health, check for any side effects, and assess how well the treatment is working. This will likely include blood tests, physical exams, and scans. The researchers will be particularly interested in observing how your body responds to Talzenna over time, especially whether your cancer remains stable for at least four months. The total duration of your involvement would depend on how your treatment progresses and the study's follow-up schedule.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment like Talzenna before it's widely available, and close medical monitoring. However, there are also potential risks, including side effects from the medication, which will be carefully explained by your doctors. The treatment may not work for everyone, or it might not work as well as hoped. It's very important to remember that you are free 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
Netherlands

Common questions

What is Talzenna (talazoparib)?

Talzenna is a medicine for breast cancer that comes as a capsule. This study will help us understand more about how it works for patients.

What is the RECAP test?

The RECAP test is a special test that researchers hope will help predict if Talzenna will be a good treatment option for someone's breast cancer.

What does 'advanced breast cancer' mean?

Advanced breast cancer means the cancer has spread beyond the breast or to other parts of the body. This study focuses on people with this type of cancer.

How long will I be in the study?

The study will closely watch how your cancer responds to Talzenna for at least four months. Your total time in the study will depend on your individual progress and the study's follow-up plan.

Will I receive the RECAP test results?

You should discuss this with your doctor, as the primary goal of the study is to evaluate the test itself. Your doctor can explain what information will be shared with you.