A trial looking at atezolizumab and chemotherapy for triple negative breast cancer

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 3
This trial is for people with triple negative breast cancer who are going to have treatment for the first time. Triple negative breast cancers are cancers whose cells don’t have receptors Open a glossary item for:
  • the hormones Open a glossary item oestrogen and progesterone 
  • the Her 2 protein Open a glossary item

More about this trial

For triple negative breast cancer, you usually have a combination of chemotherapy drugs followed by surgery. Chemotherapy before surgery is called neoadjuvant therapy Open a glossary item. It can shrink the cancer and make surgery more successful. 
 
In this trial, researchers are looking at whether adding a drug called atezolizumab to chemotherapy improves the neoadjuvant therapy. 
 
Atezolizumab (Tecentriq) is a type of immunotherapy. It works by blocking a protein that stops the immune system Open a glossary item from working properly and attacking cancer cells. 
 
Everyone taking part in this trial has one of the following neoadjuvant treatments: 
  • atezolizumab and chemotherapy 
  • dummy drug (placebo) and chemotherapy
The chemotherapy drugs you have in this trial are:
The main aim of this trial is to find out how well atezolizumab and chemotherapy work as a neoadjuvant treatment for triple negative breast cancer. 

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 
 
Who can take part
You may be able to join this trial if all of the following apply:
  • you have a newly diagnosed triple negative breast cancer and haven’t had any treatment for it
  • your cancer measures at least 2 cm across (T2, T3 or T4) and there is no sign that the cancer has spread to other distant parts of the body
  • you are willing to have surgery after neoadjuvant therapy  
  • your heart is working well 
  • you have satisfactory blood test results 
  • you have a sample of tissue available that can be used to look for a protein called PD-L1 and to confirm your diagnosis of triple negative breast cancer 
  • you are able to do everything apart from heavy physical work (performance status 0 or 1
  • you are willing to use reliable contraception during treatment and for up to a year afterwards if there is any possibility that you or your partner could become pregnant 
  • you are at least 18 years old  
Who can’t take part
 
Cancer related 
You cannot join this trial if any of these apply: 
  • you have had a previous invasive breast cancer  
  • you have breast cancer in both breasts (bilateral) 
  • your cancer has spread to other distant parts of the body (metastatic) 
  • you have had treatment for breast cancer that reached your whole body (systemic)  
  • you have had atezolizumab, doxorubicin, paclitaxel or any other similar drug 
  • you have had ductal carcinoma in situ (DCIS) unless you have had surgery to remove the breast (mastectomy) more than 5 years ago
  • you have had pleomorphic lobular carcinoma in situ (LCIS) unless you have had surgery for it more than 5 years ago 
  • you have had an operation to remove the tumour, or a piece of tumour, where the cancer first started (excision or incisional biopsy) 
  • you have had an operation to remove all the lymph nodes from the armpit or to remove the sentinel lymph node  Open a glossary iteminvolved with cancer
  • you have had another cancer in the last 5 years part from non melanoma skin cancer Open a glossary item, an early cancer of the womb, localised prostate cancer, or carcinoma in situ Open a glossary item of the cervix that has been successfully treated 
Medical conditions 
You cannot join this trial if any of these apply. You:
  • have had a stroke Open a glossary item in the last 12 months 
  • have heart problems such as an irregular heart rhythm (arrhythmia), high blood pressure or angina Open a glossary item that isn’t controlled, moderate or severe congestive heart disease, or you have had a heart attack in the last year 
  • have, or have had, an active autoimmune disease  Open a glossary itemunless it is type 1 diabetes Open a glossary item, a thyroid problem called hypothyroidism Open a glossary item, or a skin condition called psoriasis, vitiligo or eczema that is stable
  • have or have had lung problems such as pneumonitis Open a glossary item
  • take or have taken drugs that damp down (supress) your immune system such as steroids in the past 2 weeks, unless it was a very small dose or an inhaler
  • take or have taken drugs that stimulate the immune system such as interferon in the past 4 weeks
  • have HIV 
  • have hepatitis B or hepatitis C 
  • have active tuberculosis 
  • have, or have had a severe infection in the last month 
  • have taken antibiotics in the last 2 weeks 
  • have had a major surgery in the last 4 weeks, or doctors think that you will need to have an operation during this trial
  • have had an organ transplant Open a glossary item from a donor
  • have any other medical condition that the trial team think could affect you taking part
Other 
You cannot join this trial if any of these apply. You:
  • you are sensitive to any of the drugs used in this trial or anything they contain 
  • have had a live vaccine in the last month  
  • are pregnant or breastfeeding  

Trial design

This is an international phase 3 trial. Researchers hope that up to 324 people worldwide and 9 people from the UK will agree to take part. 
 
It is a randomised trial. Everyone taking part is put into 1 of the following groups by computer: 
  • atezolizumab and chemotherapy 
  • dummy drug and chemotherapy 
Neither you nor your doctor are able to choose which group you are in and neither you nor your doctor will know which group you are in. This is called a double blind trial Open a glossary item

 

Atezolizumab or dummy drug 

You have atezolizumab or dummy drug as a drip into your bloodstream (intravenously) every 2 weeks. It takes between 30 minutes and 60 minutes to have atezolizumab or dummy drug each time. 
 
You can have up to 10 treatments with atezolizumab or dummy drug, taking about 4 and a half months. 
 
Chemotherapy
Everyone has the following chemotherapy drugs:
  • nab-paclitaxel
  • doxorubicin 
  • cyclophosphamide 
First, you have nab-paclitaxel as a drip into your bloodstream every week for 12 weeks. You have it at the same time you have atezolizumab or dummy drug.
 
After 12 weeks (about 3 months), you stop nab-paclitaxel. You then have:
  • doxorubicin as a drip into your bloodstream every 2 weeks 
  • cyclophosphamide as a drip into your bloodstream every 2 weeks
You have up to 4 doxorubicin and 4 cyclophosphamide treatments, taking about 2 months in total. 
 
Breast cancer surgery
After you finish chemotherapy, you have breast cancer surgery. This is the same as the standard treatment. Your doctor can tell you more about this.
 
After surgery, you and your doctor will find out whether you have had atezolizumab or dummy drug. 
 
If you had atezolizumab, you might be able to continue to have atezolizumab after surgery. You have it every 3 weeks, for up to 11 treatments (about 8 months). 
 
If you had dummy drug, your doctor will follow you up closely after surgery. You see the doctor every 3 weeks, for up to 11 visits. This is called monitoring. 
 
After the operation, you may also have radiotherapy and chemotherapy. You have chemotherapy if doctors find cancer cells in your breast or armpit during surgery. Your doctor can tell you more about this. This is the same as the standard treatment. 
 
Tissue sample
The trial team will ask to use a tissue sample of your cancer taken when you had a biopsy. They might also ask you to give a new tissue sample: 
  • 3 weeks after the start of treatment 
  • during breast cancer surgery 
  • if your cancer comes back
You don’t need to agree to give a tissue sample 3 weeks after the start of treatment if you don’t want to. You can still take part in this trial.
 
Blood tests
You have extra blood tests as part of this trial. You have them before the start of treatment and then:
  • at set times during the trial
  • within a month after finishing treatment with atezolizumab or monitoring  
Researchers want to:
  • find out what happens to the drugs inside your body (pharmacokinetics Open a glossary item)
  • look for certain proteins (biomarkers Open a glossary item) that can help to tell how well the treatment is working
  • look at the cancer DNA Open a glossary item

Hospital visits

You see a doctor and have some tests before taking part. These tests might include: 
  • a physical examination 
  • heart trace (ECG Open a glossary item)
  • a heart scan (MUGA Open a glossary item or ECHO Open a glossary item)
  • blood tests
  • urine test
  • breast ultrasound 
  • a lung function test Open a glossary item
  • a mammogram
During treatment, you see the trial team regularly. You have blood tests and a physical examination each time you see them. You also have a heart scan at set times during this trial. 
 
You have an ultrasound before surgery and a mammogram every year. You might also have other scans such as:
 
MRI scan 
 
This is the same as the standard treatment. Your doctor can tell you more about this. 
 
When you finish treatment or monitoring, you see the trial team every 3 months, for up to 3 years. You then see the trial team every 6 months until the end of this trial. You might have a physical examination and scans every time you see them. You may also complete some questionnaires at set times. 

Side effects

The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the treatment. 
 
Atezolizumab affects the immune system. This may cause inflammation in different parts of the body which can cause serious side effects. Side effects can happen during treatment or some months after treatment has finished. In some people, these side effects can be life threatening. 
 
The most common side effects of atezolizumab are:
We have more information about the side effects of atezolizumab. And information about the side effects of:
 

Location

Leicester
London
Newcastle upon Tyne

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 Samreen Ahmed

Supported by

Roche

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16405

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

Harriet wanted to try new treatments

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“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

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