Active not recruitingPHASE2INTERVENTIONAL

Investigate the Contribution of Ipatasertib to Neoadjuvant Chemotherapy Plus Atezolizumab in TNBC

Doctors are studying whether adding a new drug called Ipatasertib to current treatments can help women with a specific type of breast cancer, known as triple-negative breast cancer. This cancer is aggressive and doesn't respond to some common treatments. The study aims to see if combining Ipatasertib with chemotherapy and another drug, Atezolizumab, works better. Participants will be women newly diagnosed with this cancer, whose cancer hasn't spread, but is considered high-risk (meaning it's in nearby lymph nodes or is a certain size). Researchers will also look at how genetic changes in the cancer might affect how well the treatment works. The goal is to find more effective ways to treat this challenging form of breast cancer before surgery.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Queen Mary University of London

Enrolment target

146

Start

19 Dec 2018

Estimated completion

31 Aug 2026

Triple Negative Breast Cancer

What is this study about?

This research is looking into a new way to treat a specific kind of breast cancer called triple-negative breast cancer. This type of cancer is sometimes harder to treat because it doesn't respond to certain common hormone-based or targeted therapies. The study wants to see if adding a new drug called Ipatasertib to the usual chemotherapy, along with another drug called Atezolizumab, can improve how well the treatment works before surgery.

Imagine combining a team of different medicines, each attacking the cancer in its own way. Chemotherapy is a standard treatment that helps shrink tumours. Atezolizumab is a type of immunotherapy, which helps your body's immune system fight the cancer. Ipatasertib is a newer drug designed to block certain signals within cancer cells that help them grow. By putting these three together, researchers hope to give the cancer a powerful one-two-three punch.

The study focuses on women who have been newly diagnosed with triple-negative breast cancer that hasn't spread to other parts of the body, but is considered more advanced or 'high-risk'. This means the cancer might be in nearby lymph nodes or has reached a certain size. The doctors will also be checking if certain genetic changes within the cancer cells affect how well these new treatments work. The aim is to find more effective treatments for this challenging cancer, potentially leading to better outcomes for patients in the future.

Key takeaways

The study is for women with newly diagnosed, high-risk triple-negative breast cancer.
It combines standard chemotherapy with two newer drugs: Atezolizumab and Ipatasertib.
The goal is to see if this new combination works better before surgery.
Participants will be randomly assigned to different treatment groups.
Researchers will study genetic changes in the cancer to understand treatment effects.
Your medical team will fully explain all aspects of the study, including benefits and risks.

Who may be eligible?

This study is for women aged 18 or older who have recently been diagnosed with triple-negative breast cancer. To be eligible, your cancer must be considered high-risk, meaning it's either in your lymph nodes or is at least 2cm in size, but it must not have spread to other parts of your body. You should also be generally well and able to carry out your daily activities.

There are certain reasons why you might not be able to join the study. For example, if you've already had any treatment for your current breast cancer, such as chemotherapy or radiotherapy, you won't be able to take part. Also, if you have other serious medical conditions like certain autoimmune diseases, uncontrolled diabetes, or particular lung conditions, or if you've had certain other cancers recently, this study might not be right for you. The medical team will check your full health history to make sure it's safe for you to participate.

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 aged 18 or over?
Have you been newly diagnosed with triple-negative breast cancer that hasn't spread?
Is your cancer considered high-risk (e.g., in lymph nodes or 2cm or larger)?
Are you generally well and able to carry out your daily activities?
Have you NOT had any previous treatment for your current breast cancer?
Do you have a healthy blood count and good organ function?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given a combination of chemotherapy drugs (Paclitaxel, Doxorubicin, Cyclophosphamide), along with Atezolizumab and Ipatasertib. These treatments are given before any surgery you might have for your breast cancer. You'll have regular hospital visits for your treatments and to have check-ups, blood tests, and scans to see how you're doing and how the treatment is working. The total duration of your active treatment period will depend on the specific treatment plan, but usually, this type of 'neo-adjuvant' treatment (treatment before surgery) lasts several months. After your main treatment, you'll continue to have follow-up appointments to monitor your health and the long-term effects of the treatment. You will also need to provide tumour samples for genetic testing.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new treatment combination that isn't widely available yet, which could be more effective against your cancer. However, like all medical treatments, there are potential risks and side effects associated with each of the drugs used in the study. Your care team will explain these in detail, covering everything from common side effects like tiredness or nausea, to more serious, but rarer, issues. 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.

Barts Health NHS Trust
Verified postcode
London, United Kingdom

Common questions

What is 'triple-negative breast cancer'?

It's a type of breast cancer that doesn't have specific features (receptors for oestrogen, progesterone, or HER2 protein) that other breast cancers might have. This means it doesn't respond to some common targeted treatments.

What does 'neo-adjuvant' mean?

Neo-adjuvant treatment is medical treatment, like chemotherapy, given before the main treatment, which is usually surgery, to shrink the tumour and make surgery easier or more effective.

What are Atezolizumab and Ipatasertib?

Atezolizumab is a drug that helps your immune system fight cancer. Ipatasertib is a newer drug designed to block signals that help cancer cells grow.

Will I definitely get the new drug combination?

This is a 'randomised' study, meaning you will be put into a treatment group by chance, like flipping a coin. This helps researchers compare the different treatments fairly.

Why do they need tumour samples?

Tumour samples help the researchers understand if certain genetic changes in your cancer affect how well the new treatment works, which could help future patients.