
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at durvalumab and paclitaxel combined with other cancer drugs for triple negative breast cancer that has spread.
Triple negative breast cancer is breast cancer that has no receptors for:
There are 2 parts to this study. This summary is about part 1.
Chemotherapy is the for triple negative breast cancer that has spread to another part of the body. One of the chemotherapy drugs that doctors use is paclitaxel.
Researchers are always looking for better treatments for triple negative breast cancer. In this study they are looking at combining and
with paclitaxel. The combinations they are looking at are:
Durvalumab, oleclumab and trastuzumab deruxtecan are a type of immunotherapy called monoclonal antibodies (MABs). They work by helping the to recognise cancer cells.
Capivasertib, selumetinib and danvatirsen are a types of targeted cancer drugs called cancer growth blockers. They work by stopping cancer cells from growing or by causing cancer cells to die.
The aims of this part of the study are to find:
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:
For part 1 of the trial only women can take part. For part 2 both women and men can take part.
Who can’t take part
You cannot join this study if any of these apply.
Cancer related
You:
Medical conditions
You cannot join this study if any of these apply. You:
Other
You cannot join this study if any of these apply. You:
Genetic sample research
You cannot take part in the genetic research part of the study if either of the following apply. You:
There are 2 parts in this study. This is an international study.
This summary is about part 1. When part 2 opens we will include it in the summary.
Part 1
The first part is a phase 1b study.
Researchers needed 170 people worldwide to join. They have enough people for 2 treatment groups. So they now need another 110 people with 23 people from the UK.
In this part there were 6 groups but now only 4 groups are open for people to join:
The first 20 people to join the study are in group 1.
Then everyone is put into groups 2 to 5 at .
To start with 6 people are put into each group. This is to check that the combination of drugs in each group is safe. After this another 14 people go into each group.
So which group you are in depends on when you join the study.
Group 1
You have durvalumab and paclitaxel as a drip into a vein. You have durvalumab at the start of each cycle of treatment. You have paclitaxel once a week for 3 weeks. Then you have a week of no treatment. This 4 week period is a .
Group 2
You have durvalumab and paclitaxel as a drip into a vein. You have durvalumab at the start of each cycle of treatment. You have paclitaxel once a week for 3 weeks. Then a week of not having it. This is a 4 week cycle of treatment.
Capivasertib is a capsule you take twice a day. You take them for 4 days starting the day after having paclitaxel. You have a diary to write down when you have capivasertib.
You have oleclumab as a drip into a vein. For cycle 1 and cycle 2 of treatment you have it once a week for 2 weeks. For every treatment cycle after, you have it once a week at the start of each cycle when you have durvalumab and paclitaxel.
Group 6
You have durvalumab and trastuzumab deruxtecan as a drip into a vein. You have them both on the same day. You have them once every 3 weeks. This is a 3 week cycle of treatment.
For all the groups you can continue having treatment as long as it is helping and the side effects aren’t too bad.
Research samples
During the study you give blood and tissue samples for research. You have these as part of your normal routine care. They will use these samples to find out how well the treatment is working and to look for substances () that can tell them how well the treatment is working.
They will also ask for extra tissue samples:
They will also ask for extra blood samples during the study.
Researchers will use these samples to look at the genes in the cells to find out what difference they make to how well the treatment works. They will also help to find out more about the cancer.
You don’t have to agree to have these extra samples taken. You can still take part in the main study.
The researchers will store any samples for future research. You don’t have to agree to this. You can still take part in the main study.
You see the doctor to have test before agreeing to take part. These tests include:
For people in group 6 only you also have:
During treatment you see the doctor regularly. Your doctor or the study team will tell you how often this is.
You see the doctor at the end of treatment for:
You then see the doctor as part of the study:
You are monitored closely for side effects when having treatment as part of the study. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
Durvalumab, capivasertib, oleclumab and trastuzumab deruxtecan are new drugs and there might be side effects we don’t know about yet. There might also be side effects from the combination of drugs they are looking at in this study that we don’t know about yet.
Durvalumab and oleclumab can affect the immune system. They may cause inflammation in different parts of the body. This can cause serious side effects. These could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening. If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy. |
The most common side effects of durvalumab include:
The most common side effects of capivasertib include:
The side effects of durvalumab and oleclumab combined include:
The most common side effects of trastuzumab deruxtecan include:
Trastuzumab deruxtecan might cause a serious lung problem. In some cases this could be life threatening. Symptoms are similar to other heart or lung diseases. Please contact your doctor straight away if you have any new lung symptoms or symptoms that are getting worse. These include:
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We have information about the side effects of paclitaxel.
Your doctor or a member of the study team will talk to you about the possible side effects of the treatments used in this study.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Peter Schmid
AstraZeneca
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”