A study looking at immunotherapy before usual treatment for newly diagnosed breast cancer (ECLIPSE Study)

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 2
This study is looking at whether immunotherapy in combination with a targeted drug can improve treatment for breast cancer. 
 
It is for people whose cancer is HER2 negative and oestrogen (ER) positive. This means the breast cancer cells:
  • don’t have receptors for HER2 
  • do have receptors for oestrogen  

More about this trial

The level of immune cells in the area around a tumour shows the immune system’s Open a glossary item ability to find and fight cancer. Tumours that have a high level of immune cells around them are called inflamed type tumours. Tumours that have low levels of immune cells around them are called non inflamed type tumours. 
 
Immunotherapy uses the immune system to fight cancer. We know from research that having one immunotherapy drug works better in inflamed tumours than in non inflamed tumours. 
 
We also know that most breast cancers that are ER positive are non inflamed.  So, having a single immunotherapy drug doesn’t work very well. 
 
Researchers want to improve treatment for people with ER positive breast cancer. They think that having an immunotherapy drug in combination with a targeted drug might help. They hope this will switch the tumours from non inflamed to inflamed tumours. And increase the chances of an immune response. 
 
In this study, researchers are trying to work out which drugs works best to do this. They are looking at different combinations that include the following drugs:
  • atezolizumab 
  • ipatasertib
Atezolizumab is an immunotherapy drug. It blocks a protein called PD-L1 on the surface on cancer cells. This helps the immune system to find and kill cancer cells.
 
Ipatasertib is a targeted drugs called cancer growth blockers. It stops signals that cancer cells use to divide and grow. 

The main aims of the study are to:

  • find out which combination of treatment works best to produce an immune response
  • learn more about the side effects

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. 
 
Who can take part
 You may be able to join this study if all of the following apply. 
 
You:
  • have breast cancer that your surgeon can remove with an operation 
  • have breast cancer that is bigger than 1 cm across
  • have oestrogen positive receptor breast cance Open a glossary itemr  
  • have HER 2 Open a glossary item negative breast cancer  
  • have tumour samples Open a glossary item available for the study team to do some tests on
  • are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1
  • have satisfactory blood test results  
  • are willing to use reliable contraception for 14 days before treatment, during treatment and for 6 months afterwards if there is any chance you or your partner could become pregnant 
  • are at least 18 years old 
 
Who can’t take part
 
You cannot join this study if any of these apply. 
 
Cancer related
You: 
  • have a type of breast cancer called inflammatory breast cancer  
  • have had treatment with an immunotherapy drug within 28 days of joining the study or it hasn’t cleared your body properly yet
  • have already had atezolizumab, ipatasertib or similar drugs in the past
  • are having treatment with an experimental drug or taking part in another clinical trial
  • have already had treatment for this diagnosis of breast cancer (you can take part if you had treatment for a previous breast cancer or any another cancer as long as you had treatment more than 1 year ago)
  • have had any other cancer in the last 5 years apart from carcinoma insitu (CIS) of the cervix, non melanoma skin cancer, or DCIS of the breast that has been successfully treated
Medical conditions
 
You:
  • have had steroid tablets or steroid treatment as a drip into a vein in the 14 days before joining the study 
  • have an autoimmune condition such as rheumatoid arthritis or lupus
  • have a lung condition called pulmonary fibrosis
  • have an active tuberculosis infection
  • have had a stem cell transplant with someone else’s cells (allogeneic stem cell transplant) or an organ transplant 
  • have had surgery in the last 4 weeks or you have surgery planned for a condition other than breast cancer
  • have had a severe infection in the 28 days before joining the study
  • have a heart problem such as congestive heart failure or a heart attack in the 3 months before joining the study
  • have a bleeding problem 
  • are using hormone replacement therapy (you might be able to join if your doctors thinks it’s ok to stop taking it)
  • have HIV 
  • have an active hepatitis B or hepatitis C infection
Other 
You: 
  • have had a live vaccination within 28 days of starting treatment study treatment or plan to have one within 5 months after the last dose of atezolizumab
  • are sensitive to any of the drugs in the study
  • are pregnant or breastfeeding

Trial design

This phase 2 study is taking place worldwide. The researchers need 97 people to take part including about 20 from the UK.
 
It is a randomised study. You are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. 
 
You have 1 of the following:

  • atezolizumab only 
  • atezolizumab and ipatasertib


In each treatment group, you have 1 cycle of treatment. This cycle of treatment is 3 weeks. The first day of the treatment cycle is called day 1.
 
You then have the usual (standard) treatment for breast cancer. For example, surgery. Or chemotherapy or hormone therapy (neoadjuvant treatment) followed by surgery. The study doctor can tell you more about this. 
 
From diagnosis to treatment, it is usual to wait about 3 to 4 weeks. Every effort will be made to fit this trial within this window, however, it is possible that joining this study might delay treatment by 1 to 2 weeks. Your doctor will tell you more about this. 
 
Treatment
You have atezolizumab as a drip into a vein. You will have a single infusion on day 1. 
 
Ipatasertib is a tablet. You take them once a day, every day for 21 days. 

Samples for research
You give some extra blood samples during treatment. You give the samples at specific times and the study team will give you more information about this. They plan to use the samples to:

  • see how well the treatment is working
  • find out what happens to the drugs in the body
  • look for biomarkers to predict who will benefit from treatment

The research team take tumour samples (a biopsy):

  • before treatment starts 
  • at the end of 3 weeks

This is so they can examine the samples to see how well the different treatments worked.
 
The doctors will ask you to collect poo samples. They will use these to look at the microbiome in your gut. This is your normal gut flora. They think that looking at this will help work out why some people respond better to treatments than others. The study team will give you a special kit to collect the samples at home. 
 
You don’t have to agree to give the poo samples if you don’t want to. You can still take part in the main study. 

Hospital visits

You see a doctor and have some tests before you can take part. These include:

  • physical examination
  • blood tests

You might have to give a tissue sample (biopsy)

You have atezolizumab in the hospital outpatient department. You take the ipatasertib tablets at home. 
 
The study team will give you a diary. They’ll ask you to write in when you take your tablets each day. 
 
You have a check up:

  • after the 3 week treatment period 
  • at about 4 ½ months 

Side effects

As atezolizumab and ipatasertib is a new combination of treatment there may be some side effects we don’t know about yet. The study team will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything. 
 
The most common side effects of atezolizumab are:
The most common side effects of ipatasertib are:
  • diarrhoea
  • feeling or being sick 
  • skin rash 
  • high levels of sugar in the blood
  • weakness or lack of energy 
The study doctor will explain all the possible side effects before you join the study. 

Location

London
Truro

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

Prof Peter Schmid

Supported by

Queen Mary University of London
F. Hoffmann-La Roche Ltd

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15885

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

Deborah wanted to help other breast cancer patients in the future

A picture of Deborah

“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."

Last reviewed:

Rate this page:

Currently rated: 1.5 out of 5 based on 4 votes
Thank you!
We've recently made some changes to the site, tell us what you think