AuthorisedTherapeutic exploratory (Phase II)Interventional

BARBICAN: A randomised, open-label Phase II study to determine the contribution of ipatasertib to neoadjuvant chemotherapy plus atezolizumab in women with triple-negative breast cancer

The BARBICAN study is a Phase II clinical trial for women with a type of breast cancer known as triple-negative breast cancer. Researchers are testing a new approach by adding a drug called Ipatasertib to the usual treatment, which includes chemotherapy and another drug called Tecentriq. The main goal is to see if this new combination helps significantly reduce or even eliminate cancer cells in the breast and armpit before surgery. This study aims to understand how these medicines work together to fight the cancer and improve treatment outcomes for patients.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Queen Mary University Of London

Enrolment target

109

Start

08 Oct 2024

Triple-negative breast cancer

What is this study about?

This study, called BARBICAN, is looking into new ways to treat a specific kind of breast cancer known as 'triple-negative breast cancer.' This type of cancer can be more challenging to treat because it doesn't respond to some common hormone-blocking or targeted therapies.

The study combines a standard cancer treatment called chemotherapy with two other drugs: Tecentriq and a new investigational drug called Ipatasertib. Tecentriq is a type of immunotherapy that helps your own immune system fight cancer. Researchers want to find out if adding Ipatasertib to this existing combination can make the treatment even more effective at shrinking or getting rid of the cancer before surgery.

The main thing the doctors are looking for is how well the treatment shrinks the tumour. Specifically, they want to see if the cancer completely disappears from the breast and armpit lymph nodes by the time surgery happens. This is an important step in improving long-term outcomes for women with triple-negative breast cancer.

Key takeaways

This study is for women with triple-negative breast cancer.
It combines standard treatment with a new investigational drug called Ipatasertib.
The main aim is to see if the new combination shrinks tumours more effectively before surgery.
You'll receive treatment before surgery, followed by careful monitoring.
Participation involves regular hospital visits for treatments and assessments.
You can withdraw from the study at any time.

Who may be eligible?

This study is specifically for women who have been diagnosed with triple-negative breast cancer. You must be at least 18 years old to take part.

The study is looking for women who are generally well enough to undergo the treatments involved. Your doctors will check if you meet all the health requirements to ensure your safety throughout the trial.

It's important to discuss with your doctor if this study is suitable for your particular situation, as they will have all the detailed information about who can and cannot join.

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.

I am female.
I am 18 years old or older.
I have been diagnosed with triple-negative breast cancer.
My doctor believes I am generally well enough to participate in a clinical trial.

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a combination of treatments: chemotherapy, Tecentriq, and either Ipatasertib or a similar inactive substance (this is decided randomly). All participants will receive these treatments before surgery. You will likely have regular hospital visits for your treatments and check-ups. These visits will involve blood tests to monitor your health and how the treatment is working, as well as scans to track the size of your tumour. You'll also be asked to complete questionnaires about your quality of life and how you're feeling. After your surgery, you will continue to have follow-up appointments to monitor your recovery and long-term health. The total duration of participation, including treatment and follow-up, will be discussed with you in detail.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new experimental treatment that could be more effective than standard care, potentially leading to better outcomes for your cancer. However, as with all medical treatments, there are potential risks, including side effects from the medications. The doctors and nurses will closely monitor you for any side effects and provide care to manage them. You are free to withdraw from the study at any time, for any reason, without it affecting your future 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
Spain
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Unverified
Germany

Common questions

What is 'triple-negative breast cancer'?

It's a type of breast cancer that doesn't have certain features (receptors) that respond to hormone therapy or other targeted treatments, making it a bit more challenging to treat.

What is Tecentriq?

Tecentriq is a type of immunotherapy that works by helping your body's own immune system find and fight cancer cells.

What is Ipatasertib?

Ipatasertib is a new drug being tested to see if it can improve the effects of chemotherapy and immunotherapy in triple-negative breast cancer.

What does 'neoadjuvant chemotherapy' mean?

This means treatment (like chemotherapy) given before surgery to shrink the tumour, aiming to make the surgery easier and more effective.

Will I definitely receive the new drug?

This is a 'randomised' study, meaning you will be randomly assigned to receive either the new drug combination or the standard combination plus an inactive substance. Neither you nor your doctor will usually choose which one you get.