A study looking at immunotherapy before usual treatment for newly diagnosed breast cancer (ECLIPSE Study)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
- don’t have receptors for HER2
- do have receptors for oestrogen
More about this trial
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
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
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 r - have
HER 2 negative breast cancer - have
tumour samples 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
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
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
The most common side effects of atezolizumab are:
- tiredness (fatigue)
- feeling or being sick
- decreased appetite
- diarrhoea
- fever
- back or joint pain
- itchy skin or skin rash
- shortness of breath
- urine infections
- cough
- weakness or lack of energy
- diarrhoea
- feeling or being sick
- skin rash
- high levels of sugar in the blood
- weakness or lack of energy
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.
Chief Investigator
Prof Peter Schmid
Supported by
Queen Mary University of London
F. Hoffmann-La Roche Ltd
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
