
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at ipatasertib, paclitaxel and atezolizumab for breast cancer that has spread to another part of the body (advanced breast cancer).
It is for people with advanced breast cancer that has:
When you agree to take part in this trial the team will ask for a small piece of cancer tissue from when you were first diagnosed. They test this to see if your cancer has certain gene changes. Which treatment you have in the trial depends on whether your cancer has these gene changes or not.
If your cancer doesn’t have any of the certain gene changes you can’t continue to have treatment in this trial. In this case, your doctor will talk to you about what is the best treatment for you.
Ipatasertib is a targeted cancer drug called a growth blocker. It works by blocking a protein called Akt that is known to help cancer cells grow. Changes (mutations) in certain genes affect how the Akt protein works.
Paclitaxel is a chemotherapy drug used for breast cancer.
Early studies suggest that combining ipatasertib with paclitaxel might improve how well the treatment works.
In this trial you will have one of the following:
Atezolizumab is a type of immunotherapy. It blocks a protein called PD-L1. This triggers the immune system to attack and kill cancer cells.
Early studies suggest that adding atezolizumab to ipatasertib and paclitaxel might work for advanced triple negative breast cancer.
If you have triple negative breast cancer and it doesn’t have at least 1 of the gene changes that affect the Akt protein you will have ipatasertib, paclitaxel and atezolizumab.
The researchers want to find out:
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 enter
You may be able to join this trial if your cancer is one of the following, it has:
And all of the following apply:
Who can't take part
You cannot join this trial if any of these apply.
Cancer related
You:
Medical conditions
You have:
Other
You are:
This is a phase 3 trial. There are 2 groups in this trial.
Group A
This group is for people with breast cancer with receptors for hormones oestrogen and, or progesterone and none or few receptors for the HER2 protein (hormone positive/HER2 negative breast cancer).
The researchers need 450 people to join.
It is a randomised trial. You are put into 1 of 2 treatment groups. Neither you or your doctor can choose which group you are in. And neither you or your doctor will know which group you are in. It is a double blinded trial.
The 2 groups are:
2 out of every 3 people are put into the ipatasertib and paclitaxel group.
You have treatment in 4 week periods called treatment cycles.
Ipatasertib and the dummy drug are tablets. You take 2 tablets every day for 3 weeks then you have a week off.
You have paclitaxel as a drip into a vein. You have it once a week for 3 weeks then have a week off. The drip takes an hour.
This is one cycle of treatment. You then start the next cycle of treatment.
You continue having treatment as long as it is helping you and the side effects aren't too bad.
Group B
This group is for people with breast cancer that has no receptors for the hormones oestrogen and progesterone or the protein HER2 (triple negative breast cancer) and no gene changes.
In this group the researchers need 100 people to join. Everyone has ipatasertib, atezolizumab and paclitaxel.
You have treatment in 4 week periods called treatment cycles.
Ipatasertib and the dummy drug are tablets. You take 2 tablets everyday for 3 weeks and then have a week off.
You have atezolizumab as a drip into a vein. You have it once a week for 2 weeks and then have 2 weeks off. The drip takes between 30 minutes and 60 minutes.
You have paclitaxel as a drip into a vein. You have it once a week for 3 weeks then have a week off. The drip takes an hour.
This is one cycle of treatment. You then start the next cycle of treatment.
You continue having treatment as long as it is helping you and the side effects aren't too bad.
Information about paclitaxel and ipatasertib
Paclitaxel can cause an allergic reaction. To prevent this, you have some medication to take at home 12 hours and 6 hours beforehand. This is pre medication. Your doctor or nurse will tell you about this.
Ipatasertib and paclitaxel can cause diarrhoea. You might be given some anti diarrhoea tablets to take home. If you do have diarrhoea after treatment:
Patient diary
You have a patient diary to write down:
Quality of life
You fill in a couple of questionnaires:
The questions will ask about:
Blood and tissues samples
You will have regular blood tests to monitor your safety. For some samples you cannot eat or drink, apart from water, for 8 hours before having the blood sample taken. Your doctor or nurse will tell beforehand when you’re going to have these tests.
They will use these blood samples to look for substances (biomarkers) in your blood. These biomarkers might help them better understand this type of breast cancer. And to find out what happens to ipatasertib in your body.
The team will ask for a small piece of cancer tissue from when you were first diagnosed. They will use this to find out if your cancer has the changes in the genes that affect the Akt protein. They will ask for an new sample (biopsy) if this isn’t available.
They will use any remaining tissue to help them understand this type of breast cancer better.
Other information
During treatment and for 10 days after finishing treatment you can’t:
Your doctor will talk to you more about this including medications you can and can’t have.
You see the doctor to have some tests before taking part in the trial. These include:
During treatment you see the doctor every week for a physical examination and to see how you are.
You see the doctor a month after finishing treatment for some of the same tests you had before the start of treatment.
About every 3 months after treatment you see the doctor or a member of the trial team will phone you to:
You have a CT scan or MRI scan every 8 weeks until your cancer starts to grow again.
Your doctor and nurse will monitor you closely for any side effects. Let your doctor or nurse know as soon as possible if:
Early treatment can help manage side effects better, especially diarrhoea and sickness.
Ipatasertib is a new drug. There may be side effects we don’t know about when it is used by itself or in combination with other drugs.
The most common side effects reported so far include:
The most common side effects of atezilozumab include:
Atezilozumab increases the number of immune cells in your cancer tissue and healthy tissue. This can cause inflammation. The inflammation in the healthy tissue migth cause an autoimmune condition.
We have information about the side effects of paclitaxel.
Your doctor will talk to you about the possible side effects of the drugs used in this trial before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Chris Poole
Roche
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.