A study of atezolizumab for people with triple negative breast cancer that has spread

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Phase 3

This study is for people who have cancer that has spread locally and surgery is not possible or it has spread elsewhere and you haven’t had treatment. Triple negative breast cancers are cancers that don’t have receptors Open a glossary item for oestrogen, progesterone or Her2.

More about this trial

Chemotherapy is the main treatment for triple negative breast cancer that has spread.  In this study doctors want to see if adding a biological therapy called atezolizumab will improve treatment.

Atezolizumab is a drug that uses your immune system to help fight the cancer. It works by affecting a substance called PD-L1.  When cancer cells have a lot of PD-L1 on their surface, the immune system doesn’t work properly in getting rid of them. 

Atezolizumab blocks the way PD-L1 works (the PD-L1 pathway) and so it could help your immune system to stop or shrink the cancer growth. 

Cancers with large amounts of PD-L1 are described as being PD-L1 positive
The main aim of this study is to

  • find out how useful and safe giving atezolizumab with chemotherapy is 

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

You may be able to join this study if all of the following apply. You

  • Have been diagnosed with triple negative breast cancer which has spread locally (locally advanced cancer) and you can’t have surgery to remove it. Or your cancer has spread to another part of your body (metastatic or secondary breast cancer)
  • Have an area of cancer that can be measured
  • Have not had chemotherapy or any other anti cancer treatment that treats your whole body (systemic treatment) for your cancer. You must have finished this treatment at least 12 months ago if you had chemotherapy before or after surgery for your breast cancer 
  • Must have a sample of tissue available for testing. If you have had a sample taken (a biopsy Open a glossary item) in the past and have had anti cancer treatment since then, you will need to have another biopsy 
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1
  • Have satisfactory blood test results
  • Are willing to use reliable contraception during the study if there is any chance that you or your partner could become pregnant. You should also use reliable contraception for up to 5 months following treatment if you are female and for 6 months following treatment if you are male
  • Are at least 18 years old

You cannot join this study if any of these apply. You

  • Have cancer pressing on your spinal cord (spinal cord compression) and you haven’t had surgery or radiotherapy or you have been treated and you still have symptoms 
  • Have cancer spread to the brain and spinal cord (central nervous system). You can take part if the cancer has spread to certain areas of your brain, it has been treated with surgery or radiotherapy, is not getting worse and you do not need steroid treatment.
  • Have cancer spread to the covering (the meninges) of the brain or spinal cord (leptomeningeal disease)
  • Have a fluid build up in your tummy (abdominal ascites) or around your heart (pericardial effusion) or in your lungs (pleural effusion) that is causing you problems and which keeps coming back after treatment
  • Have cancer pain that is not controlled
  • Have high levels of calcium in your blood (hypercalcemia) that medication is not controlling or which you need to have continuous bisphosphonate treatment 
  • Have had any other cancer in the last 5 years, unless it was a very early stage and has been successfully treated 
  • Have or have had an autoimmune disease Open a glossary item such as rheumatoid arthritis, inflammatory bowel disease, multiple scelrosis, myasthenia gravis. If you have auto immune related hypothyroidism and are on a stable dose of thyroid replacement hormone you can take part in the study. If you have an autoimmune condition of your skin such as eczema, psoriasis, lichen simplex chronic or vitiligo you can take part as long as your condition is well controlled and less than 10% of your skin is covered by the condition and you have not needed to have oral medication to treat a flare up in your condition in the last 12 months
  • Have a liver disease such as cirrhosis 
  • Have certain heart conditions such as a heart attack in the last 3 months, problems with the rhythm of your heart, angina that is not controlled with medication, or congestive heart failure or coronary artery disease that affects the way your heart is working
  • Have certain lung conditions such as pnuemonitis – if you have pneumonitis caused by radiotherapy you can still take part
  • Have a severe infection within 4 weeks of starting the study
  • Have had oral antibiotics or antibiotics into your blood stream (intravenous) in the 2 weeks before starting the study treatment. Some antibiotics given to prevent an infection will be allowed - the study doctors can advise you
  • Have a live vaccine within 4 weeks or starting the study or be due to have one during the study
  • Have HIV
  • Have active hepatitis B or hepatitis C
  • Have tuberculosis and you have symptoms (active TB)
  • Have had major surgery within 28 days of starting the study or you are due to have major surgery during the time you are in the study
  • Have ever had a stem cell or organ transplant from a donor
  • Have had treatment with certain biological therapies such as CD137 agonists and immune checkpoint blockade therapies (including anti-CTLA-4, anti-PD-1 or anti-PD-L1 therapeutic antibodies) for example nivolumab, pembrolizumab, atezolizumab, or ipilimumab,
  • Have had treatment with drugs that encourage the immune system to fight cancer such as interferon or interleukin 2 (IL2) within 4 weeks of starting the study or there is still traces of these drugs in your blood
  • Have had treatment with corticosteroids or any other type of drug that suppresses your immune system within 2 weeks of starting the study or be due to have these types of drugs during the study. Some types of steroid therapy will be allowed- the study doctors can advise you
  • Are allergic or sensitive to nab paclitaxel or any of its ingredients
  • Are allergic or sensitive to atezolizumab or any of its ingredients or any drugs produced in Chinese hamster ovary cells
  • Have had a severe allergic reaction (including anaphylaxsis) or any other sensitivity to monoclonal antibodies
  • Are pregnant or breastfeeding

Trial design

This is a phase 3 international study. Doctors need about 40 people in the UK to take part. 

It is a randomised study. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. There are 2 treatment groups

  • one group have atezolizumab and nab-paclitaxel
  • the other group have a dummy drug (placebo) and nab-paclitaxel

Diagram for randomised trial design

You have the drugs into the bloodstream (intravenously). You have it over 28 days. This includes days when you have the drugs and then time when you have no treatment to allow your body to recover. This is called a cycle of treatment

The first day of treatment is called day 1. You have 

  • atezolizumab or the dummy drug on days 1 and 15
  • nab-paclitaxel on days 1, 8 and 15

If you have side effects from one of the drugs that can’t be managed it can be stopped and you can continue with the other drug. 

You will have at least 6 cycles of nab-paclitaxel and this can continue if the doctors think it is helping you. You can have atezolizumab or the dummy drug for as long as it is helping you.

If your cancer gets worse the treatment will stop and the doctors will discuss different options with you. 

Quality of life questionnaires
You will complete 3 questionnaires at different points in the study and once you have finished treatment. These ask questions about your breast cancer symptoms and how your cancer and the treatment affect your day to day life. These are called quality of life studies

Tissue and blood samples
You have extra blood tests as part of this study. This is so the doctors can

  • learn more about how atezolizumab works in the body with and without nab-paclitaxel
  • learn more about substances called biomarkers [Gloss/biomarkers] and the way your cancer responds to treatment

You need to have a tissue sample (a biopsy Open a glossary item

  • before you start in the study if you have had treatment for your breast cancer after having a biopsy or removal of your cancer
  • if your cancer gets worse. This will only be done if the doctor thinks it is possible

Your doctors might ask you to have other blood and tissue samples during the time you’re in the study. This is for future research related to cancer and other diseases. You do not have to give these additional samples if you don’t want to, you can still take part in the study. 

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include 

  • Blood tests
  • Urine test
  • A physical examination
  • Heart trace (ECG Open a glossary item)
  • CT scan or MRI scan

You may also have a 

You go to hospital for your treatment. You should not need to stay overnight. You have regular blood tests during the time you have treatment. These are to check your general health and to see how the drugs are working in your body. 

You have a scan every 8 weeks for 12 months. Then you have one 3 monthly. The type of scan you have depends on which one the doctor thinks is best at measuring the cancer in your body. The study team will explain this further. 

After you finish treatment in the study the doctors will follow you up. This will be every 8 weeks. You complete questionnaires about your symptoms every 28 days.

Side effects

As atezolizumab is a new drug, there may be side effects we don’t know about yet. The study team will monitor you during the time you have treatment and you will be given a phone number to call them if you are worried about anything.

The most common side effects of atezolizumab are

The most common side effects of nab-paclitaxel are 

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness 
  • Numbness tingling and a burning sensation in your hands and feet (peripheral neuropathy)
  • Joint pain
  • Muscle aches
  • Feeling weak and lacking energy
  • Feeling or being sick
  • Diarrhoea
  • Hair loss 
  • Loss of appetite
  • Constipation
  • Shortness of breath
  • Skin rash
  • Infection 
  • Swelling of your hands and feet
  • Changes to your heart rate- you might not have any symptoms associated with this and it may just be found during a physical examination or a heart trace (ECG)

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Peter Schmid

Supported by

Roche
Experimental Cancer Medicine Centre (ECMC)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13835

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Caroline took part in a clinical trial for breast cancer

“I had treatment last year and I want to give something back.”

Last reviewed:

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