Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

"neoBREASTIM": A Phase 2 Study of Atezolizumab plus RP1 oncolytic immunotherapy in the NeoAdjuvant setting of Triple-Negative Breast Cancer (TNBC)

This study, called "neoBREASTIM," is looking at new treatments for early-stage Triple Negative Breast Cancer (TNBC) before surgery. Researchers want to know how safe two experimental medicines, Tecentriq and Vusolimogene oderparepvec, are when given together. They are also checking how well these medicines shrink the cancer. This is a "Phase 2" study, meaning it's an early step to see if the treatment works and is safe enough to study further in more people. The main goal is to see how much cancer is left after treatment and before surgery, especially in patients whose cancer isn't growing during treatment. Researchers will also be looking closely at any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institut Curie

Enrolment target

Start

18 Aug 2023

Patients with early-stage Triple Negative Breast Cancer

What is this study about?

This study, called "neoBREASTIM," is focused on a specific type of breast cancer known as Triple Negative Breast Cancer (TNBC). "Triple Negative" means the cancer cells don't have certain receptors (like switches) that are often targeted by other breast cancer medicines. This makes TNBC more challenging to treat, and researchers are constantly looking for new approaches.

In this study, doctors are investigating two medicines given together before surgery. One is called Tecentriq (its scientific name is Atezolizumab), which is a type of immunotherapy. Immunotherapy works by helping your body's own immune system fight cancer. The other medicine is Vusolimogene oderparepvec, which is an 'oncolytic immunotherapy.' This means it's designed to attack cancer cells directly while also helping the immune system. Giving these medicines before surgery is called 'neoadjuvant treatment' and aims to shrink the tumour, making surgery potentially more effective.

This is a Phase 2 study. In medical research, studies go through different phases. Phase 1 focuses on safety, Phase 2 looks at how well the treatment works and continues to monitor safety in a larger group, and Phase 3 compares the new treatment to existing ones. This study will focus on how safe the combination of these two medicines is and how much the tumour shrinks before surgery, particularly in patients where the cancer doesn't seem to be getting worse during the treatment.

Key takeaways

This study explores a new way to treat early-stage Triple Negative Breast Cancer.
It combines two experimental immunotherapies, Tecentriq and Vusolimogene oderparepvec.
The treatments are given before your planned surgery.
The main goals are to check for safety and how well the treatment shrinks the cancer.
It's a Phase 2 study, an early step in testing new treatments.

Who may be eligible?

To be considered for this study, you need to be an adult woman, at least 18 years old, who has been diagnosed with early-stage Triple Negative Breast Cancer.

The study team will check many other things to make sure the treatment is suitable and safe for you. This often includes looking at your other health conditions, past medical history, and current medications. These are important steps to ensure the study is right for you and that the results can be properly understood.

It's important to discuss your full medical history with the study doctor to see if you meet all the requirements to take part.

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 an adult woman?
Are you at least 18 years old?
Have you been diagnosed with early-stage Triple Negative Breast Cancer?
Are you able to attend regular appointments and receive infusions?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive the two study drugs, Tecentriq and Vusolimogene oderparepvec, as infusions (given through a drip) before your planned breast cancer surgery. The study involves regular visits for these infusions and to check your health, conduct blood tests, and scan your cancer to see how it's responding.

Specifically, the study will closely monitor any side effects you might experience. Researchers will also take samples, including tissue samples from your tumour, at different times to understand how the treatment is working. Your blood will also be monitored for changes that might indicate how the cancer is responding.

The duration of your participation will involve the period of receiving treatment before surgery and follow-up checks after surgery. The total length of the study for an individual participant can vary, but typically it involves treatment cycles leading up to surgery and then ongoing monitoring for several years to track health outcomes like whether the cancer returns.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new and innovative treatments that are not yet widely available. While the main goal is to find better treatments, there's no guarantee the treatment will work for you. There are potential risks involved, as with any medical treatment. These new medicines can cause side effects, which the study team will monitor very carefully. These can range from mild to more serious and will be explained in detail. 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
France

Common questions

What is Triple Negative Breast Cancer (TNBC)?

TNBC is a type of breast cancer where the cancer cells don't have three specific features (receptors) that are often targeted by other breast cancer treatments. This means doctors need different ways to treat it.

What do 'Tecentriq' and 'Vusolimogene oderparepvec' do?

Tecentriq is a type of immunotherapy that helps your body's own immune system fight cancer. Vusolimogene oderparepvec is also an immunotherapy, but it's designed to directly attack cancer cells and then help get your immune system involved.

Why are these medicines given before surgery?

Giving medicines before surgery is called 'neoadjuvant treatment.' The aim is to shrink the cancer first, which can make the surgery easier and more effective for some patients.

What does 'Phase 2 study' mean?

A Phase 2 study is an early stage of clinical research. It mainly focuses on seeing if a new treatment is safe enough to continue studying and whether it shows promising signs of working against the disease.

Will I still have surgery if I join this study?

Yes, this study involves giving treatments before your planned breast cancer surgery to see if they can shrink the tumour and make surgery more effective.