Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A–BRAVE-Trial. ADJUVANT TREATMENT FOR HIGH-RISK TRIPLE NEGATIVE BREAST CANCER PATIENTS WITH THE ANTI-PD-L1 ANTIBODY AVELUMAB: A PHASE III RANDOMIZED TRIAL

This research, called the A–BRAVE-Trial, is studying a new medicine called Bavencio for people who have been diagnosed with a type of breast cancer known as 'triple negative breast cancer'. This type is often more aggressive. The study is particularly looking at patients who have a higher chance of their cancer returning. We want to see if giving Bavencio after their standard cancer treatment helps prevent the cancer from coming back or spreading. This is a big, important study (a Phase III trial) where some patients will receive the new medicine and others won't, so we can carefully compare the results. The main goal is to find out if Bavencio can increase the time people live without their disease returning.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Universita Degli Studi Di Padova

Enrolment target

450

Start

25 Nov 2024

Breast Cancer

What is this study about?

This study is called the A–BRAVE-Trial and it's looking into a new treatment for a specific kind of breast cancer that's known as 'triple negative'. This type of breast cancer is often more challenging to treat because it doesn't respond to some of the common hormone or targeted therapies. If you've been told you have high-risk triple negative breast cancer, it means there's a greater chance of your cancer returning after your initial treatments.

The researchers want to see if a medicine called Bavencio (which is a type of immunotherapy) can help. Immunotherapy works by boosting your body's own immune system to fight cancer cells. The idea is to add Bavencio to the care you've already received, hoping it will reduce the chance of the cancer coming back in the future. This is a 'Phase III' study, which means it's a large trial designed to confirm if a new treatment is effective and safe before it can be widely used.

The main thing the study will measure is how long people live without their cancer coming back. They'll also look at overall survival, which means how long people live after starting the study. By comparing people who receive Bavencio with those who don't, doctors can learn if this new treatment can make a real difference for patients with this type of breast cancer.

Key takeaways

This study is for high-risk triple negative breast cancer.
It tests a new immunotherapy medicine called Bavencio.
The aim is to prevent cancer from returning after initial treatment.
It's a large, important study (Phase III) to check effectiveness.
Participation involves regular hospital visits for treatment and checks.

Who may be eligible?

To be able to join this study, you must be at least 18 years old. Both men and women can participate if they meet the other specific requirements. There isn't an upper age limit mentioned for this study.

The study is specifically for people diagnosed with 'high-risk triple negative breast cancer'. This means your doctors will have looked at your cancer and decided that it has certain features that make it more likely to return. You would have already received some initial treatments for your cancer.

There will be other detailed medical criteria that your doctor will check to see if this study is suitable for you. These criteria are in place to make sure the study includes people who will benefit most from the research and to keep everyone safe.

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.

Am I at least 18 years old?
Do I have 'high-risk triple negative breast cancer'?
Have I already received my initial cancer treatment?
Am I prepared for regular hospital visits and treatments?
Am I willing to be randomly assigned to a treatment group?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance (like flipping a coin) to either receive the new medicine, Bavencio, or continue with standard monitoring. This is done so researchers can fairly compare the two groups. You'll receive Bavencio as an infusion (drip) into your vein. The schedule for these infusions and how long you receive the treatment will be explained in detail by the study team.

You'll have regular hospital visits, including blood tests, physical examinations, and scans, to check how you're doing and if the treatment is working. These visits will also help the doctors keep an eye on any side effects you might experience. After your treatment period, you'll have follow-up visits to monitor your health over time. The total length of your participation, including treatment and follow-up, can vary but will be fully explained by the study team.

Potential risks and benefits

Taking part in a clinical trial might offer the potential benefit of accessing a new treatment before it's widely available, which could be helpful if your cancer is high-risk. However, there's no guarantee that the new treatment will work for you or that it will be better than standard care. Like all medicines, Bavencio can have side effects, which can range from mild to serious. The study team will explain all known side effects. You are free to withdraw from the study at any time and 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
Italy

Common questions

What is 'triple negative breast cancer'?

It's a type of breast cancer that doesn't have certain receptors that common hormone or targeted therapies use, making it harder to treat with those specific medicines.

What is Bavencio?

Bavencio is an immunotherapy medicine. It helps your body's own immune system find and fight cancer cells more effectively.

What does 'Phase III' mean for a clinical trial?

Phase III means it's a large, important study comparing a new treatment to existing ones to see if it's better or safer, before it can be used more widely.

Will I definitely get the new medicine?

Because it's a 'randomised trial', you'll be assigned by chance to either receive Bavencio or continue with standard care, so we can compare the two fairly.

What does 'disease-free survival' mean?

It's the main thing the study measures. It means how long a person lives without their cancer coming back, spreading, or developing a new cancer before death.