
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is for people with triple negative breast cancer that has come back or spread to another part of the body.
Triple negative breast cancers are cancers without for:
The chemotherapy drug paclitaxel is a usual treatment for triple negative breast cancer that has come back or spread elsewhere in the body. But researchers are looking for ways to improve treatment. In this trial, they are looking at adding a drug called capivasertib.
Capivasertib is a targeted drug called a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
In this trial, some people have paclitaxel and capivasertib. And some have paclitaxel and a dummy drug ().
The aims of this trial are 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 take part
You may be able to join this trial if all of the following apply.
You:
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
Medical conditions
You:
Other
You:
This is an international phase 3 trial. The researchers hope 800 people will take part, including 25 from the UK.
This trial is randomised. You are put into 1 of the following treatment groups by computer:
You have treatment in cycles. Each 4 week period is a cycle of treatment. You have treatment for 3 weeks out of 4. The first day of each treatment cycle is called day 1.
You have paclitaxel as a drip into a vein. You have it on:
You have up to 6 cycles of paclitaxel. This takes about 6 months.
Capivasertib and the dummy drug are tablets. You start taking them the day after you have paclitaxel. You have treatment for 3 weeks out of 4.
You:
You don’t eat or drink anything for 2 hours before you take the tablets. And for 1 hour afterwards. You should also avoid having herbal supplements such as St John’s wort. And food or drink that affect an enzyme called CYP such as grapefruit or Seville oranges. These can affect how the body absorbs capivasertib.
You have capivasertib or the dummy drug as long as it’s working, and the side effects aren’t too bad. This decision is normally made after a discussion with your doctor.
Quality of life
You fill out a questionnaire before starting treatment, at set times during the trial and after finishing treatment. The questionnaire will ask about any side effects you have had and about how you have been feeling. These are quality of life questionnaires.
Blood and tissue research samples
You have extra blood tests as part of this trial. Where possible you have them at the same time as your routine samples.
Researchers will ask to use a sample of your cancer () taken during surgery. They want to look for certain
and
to find out more about triple negative breast cancer and how the treatment works.
Doctors might also ask you to give a tissue sample before you start treatment and if your cancer comes back.
You see a doctor or a nurse and have some tests before taking part. These tests might include:
During treatment, you see the trial doctor for regular check ups. The trial team will explain more about when these take place.
You have a CT scan or MRI scan every:
You have these trial scans until the cancer gets worse.
Capivasertib is a new drug so there might be some side effects we don’t know about yet.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better. The trial team will also give you a number to call if you are worried about anything.
Some possible side effects of capivasertib include:
We have information about the side effects of paclitaxel.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Prof Peter Schmid
AstraZeneca AB
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.