A trial of capivasertib for triple negative breast cancer (CAPItello 290)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Secondary cancers

Status:

Closed

Phase:

Phase 3

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 receptors Open a glossary item for:

oestrogen
progesterone
HER2

More about this trial

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 (placebo Open a glossary item ).

The aims of this trial are to find out:

if the combination of capivasertib and paclitaxel works better than paclitaxel only for triple negative breast cancer
more about the side effects

Who can enter

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:

have triple negative breast cancer (your cancer doesn’t have receptors for the hormones oestrogen and progesterone or the Her2 protein)
have breast cancer that has come back and can’t be removed with an operation or it has spread elsewhere in the body
are suitable to have paclitaxel chemotherapy
have cancer that the doctor can measure on a scan
have a tumour sample (biopsy ) available for the trial team to do some tests on
are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
can swallow tablets
have satisfactory blood test results
are willing to use 2 forms of reliable contraception for up to 6 months after stopping treatment if there is any chance you or your partner could become pregnant
are at least 18 years

Who can’t take part

You cannot join this trial if any of these apply.

Cancer related
You:

have already had treatment for breast cancer that has come back or spread elsewhere in the body
have spinal cord compression or cancer spread to the brain unless it has been treated, you don’t have symptoms and you haven’t had steroids in the last 4 weeks
have had certain targeted drugs which affect how your cells grow
have had capivasertib in the past
have had chemotherapy before or after surgery in the 12 months before starting the treatment in this trial
have had any other chemotherapy, immunotherapy or treatment to damp down the immune system within the 3 weeks of the first dose of the trial treatment (6 weeks if you had a drug called mitomycin C or a nitrosoureas )
have had radiotherapy to a large area of the breast within 4 weeks of starting the trial medication
have taken part in a clinical trial in the last 30 days or the trial drug hasn’t cleared your body yet
have side effects from past treatments that aren’t getting better unless they are mild, apart from hair loss
have had any other cancer in the last 5 years apart from CIS of the cervix, basal cell skin cancer , squamous skin cell cancer or early stage cancer of the womb

Medical conditions
You:

have a problem with how your immune system works
had major surgery in the last 4 weeks
have numbness or tingling in your hands or feet unless it is mild
have or had a condition called interstitial lung disease or pneumonitis and you had or are having steroids
have extra risk factors for a heart condition called torsade de pointes, a family history of an abnormal heart rhythm called long QT syndrome or some other heart related conditions
have problems with your heart, such as a heart attack in the last 6 months, high blood pressure and/or angina that is not well controlled
have diabetes
have a problem with the way your blood clots
have sickness that isn’t controlled, a problem with your digestive system and you can’t absorb medication properly or you have had your bowel or part of your bowel removed
have had a bone marrow transplant with somebody else’s cells or an organ transplant in the past
have an active hepatitis B or hepatitis C infection
have HIV
have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial

Other
You:

are allergic to capivasertib, paclitaxel or anything they contain
are pregnant or breastfeeding

Trial design

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:

paclitaxel and capivasertib
paclitaxel and a dummy drug

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Neither you nor your doctor can decide which group you are in.

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:

day 1
day 8
day 15

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:

have the tablets on days 2 to 5
don’t have tablets on days 6 or 7

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 (biopsy Open a glossary item ) taken during surgery. They want to look for certain biomarkers and genes 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.

Hospital visits

You see a doctor or a nurse and have some tests before taking part. These tests might include:

a physical examination
heart trace (ECG )
CT scan or MRI scan
bone scan (if the cancer has spread to your bones)
heart scan (echocardiogram or a MUGA )
blood tests
urine tests

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:

8 weeks for 2 years
12 weeks after that

You have these trial scans until the cancer gets worse.

Side effects

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: