A trial to find out how useful a blood test is to monitor people with breast cancer (TRAK-ER)

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 2

This trial is looking at whether a blood test can find cancer that has come back before doctors can see it on a scan. It is also looking at whether treatment with palbociclib combined with fulvestrant is better than standard hormone treatment for these people.

The trial is open to people:

with breast cancer that is oestrogen positive (ER positive) and doesn’t have the HER2 protein (HER2 negative)
who have had treatment and are at a high risk of the cancer coming back

More about this trial

Doctors can treat ER positive and HER2 negative breast cancer with hormone therapy. Unfortunately for some people their cancer can come back.

To check for cancer coming back doctors use scans such as a CT scan Open a glossary item or a bone scan .

There are 2 parts to this trial. The first is the surveillance part.

In this part the team use a blood test that might be able to tell if your cancer has come back before it shows on a scan. This test looks for small pieces of cancer DNA in the blood. This is circulating tumour DNA Open a glossary item (ctDNA).

The team take blood samples at regular times and test it for ctDNA. If they find ctDNA the team might ask you to join the treatment part. To take part in the trial you must be prepared to go into the treatment part if asked.

Doctors already use palbociclib and fulvestrant to treat breast cancer.

In the treatment part half the people have palbociclib in combination with fulvestrant. The other half have standard hormone therapy.

The aims of this trial are to find out:

how often ctDNA occurs in people with ER positive and HER2 negative breast cancer
how useful ctDNA is to monitor these people
whether the combination of palbociclib and fulvestrant can delay or stop the cancer coming back
how this treatment combination affects quality of life

Who can enter

The following bullet points are a summary of 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.

There are 2 parts to this trial. There are different entry conditions for the surveillance part and the treatment part.

Who can take part

You may be able to join both parts of this trial if all of the following apply. You:

have breast cancer that has receptors for oestrogen (ER+) and doesn’t have the HER2 protein (HER2-)
have breast cancer that is at a high risk of coming back
have tissue samples (biopsies ) from when you were diagnosed or from your surgery that the team can ask for
are up and about, can look after yourself but might not be able to work (performance status 0, 1 or 2)
are willing to use contraception during the trial and for a time after. This is if there is any chance you or your partner could become pregnant.
are at least 18 years old

You may be able to join the surveillance part of the trial if all of the following also apply. You:

have had surgery where a border of cancer free tissue was also removed (clear margins )
have had standard hormone treatment for at least 6 months and no more than 7 years
are willing to give frequent blood samples

You may be able to join the treatment part if all of the following also apply. You:

have satisfactory blood test results
are willing to have a drug called goserelin during treatment. This is for people who haven’t gone through the menopause.

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

have cancer that spread to another part of the body. Or you have cancer that has spread into the surrounding tissue (locally advanced) that cannot be treated with the aim to cure.
are having or planned to have another cancer treatment apart from standard hormone therapy or a bisphosphonate
have had a certain targeted drug as part of your treatment. This is unless you had it only before your surgery or it has been more than a year after finishing the drug. Your doctor will know which targeted drug this is.
have already had fulvestrant
have ongoing side effects of any treatment. This is apart from hair loss and some other side effects which your doctor will know about.
have another cancer within the past 5 years. This is apart from non melanoma skin cancer and in situ carcinoma of the cervix.

Medical conditions
You cannot join this trial if any of these apply. You:

have heart problems that could affect you taking part
have problems with your digestive system such as Crohn’s disease, feeling sick and vomiting that isn’t controlled that can affect how well your body absorbs medication
have inflammation, scarring of or damage to the lung tissue
have HIV, hepatitis B or hepatitis C
have a problem with your liver or kidneys
have a problem with bleeding. You are taking certain medication such as warfarin to thin your blood. There are certain blood thinning medications that are allowed. Your doctor will know which ones these are.
are taking medication or herbal supplements that affect the CYP3A enzyme. This is unless a different medication can be used or you can stop taking them at least 1 week before starting treatment. This is for the treatment stage only.
have any other medical condition or mental health problem that could affect you taking part in the trial.

Other
You cannot join this trial if any of these apply. You:

are allergic or sensitive to palbociclib, fulvestrant or any of their ingredients. This applies to the treatment stage only.
are pregnant or breastfeeding

Trial design

This is a phase 2 trial.

There are 2 parts to the trial.

Surveillance part
In this part the team need 1,100 people to take part. When you agree to join the surveillance part you must be prepared to take part in the treatment part if asked to.

You give blood samples every 3 months for up to 3 years.

The trial team are looking for small pieces of the DNA of your cancer in the blood (ctDNA). If the team find ctDNA you have scans such as a CT scan or bone scan to see if the cancer has come back.

The team will ask you to take part in the treatment part if the scans show no cancer.

The team won’t ask you to join the treatment part if the scans do show the cancer has come back. You will no longer take part in the trial. Your doctor will talk to you about what your next treatment might be.

Treatment part
In this part the team need 132 people to take part.

This part is a randomised trial. A computer puts you into 1 of 2 groups. Neither you nor your doctor can choose which group you are in. The groups are:

palbociclib and fulvestrant
standard hormone therapy

Diagram 1

Palbociclib are capsules. You take them once a day for 3 weeks. You then have a week of not taking them. Each 4 week period is a cycle of treatment Open a glossary item .

You have fulvestrant as an injection in the muscle. A nurse gives you the injection into your buttocks. You have the first 2 injections 2 weeks apart. And then you have 1 injection every 28 days.

You continue to have palbociclib and fulvestrant for up to 2 years as long as it is helping and the side effects aren’t too bad.

After the 2 years your doctor will talk to you about whether you should continue with a standard hormone therapy.

In the standard hormone group you continue with your current treatment or you might be able to change to a different treatment. Your doctor will talk to you about this when you join this part of the trial.

Samples for research
During the trial if your cancer comes back the team will ask for a tissue sample (biopsy Open a glossary item ) of it.

Quality of life
During the treatment part you fill in a questionnaire. The questions ask about:

your general health and wellbeing
what you are able to do
about side effects and symptoms

This is a quality of life questionnaire.

Hospital visits

You see the doctor before joining the trial. This is to tell you about the trial and see if you can join.

Surveillance visits
You see the doctor to have blood samples taken every 3 months for 3 years. After the 3 years the trial team will phone you every 6 months for another 2 years.

Treatment visits
You see the doctor before starting treatment to have tests. These tests include:

a physical examination
CT scan and bone scan
blood tests
heart trace (ECG )
urine sample

You see the doctor:

twice in the first 2 months of treatment
then every 3 months while in treatment
at the end of treatment
a month later
then every 6 months to 5 years

You have a CT scan and bone scan every 6 months.

Side effects

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.

We have information about:

Your doctor will talk to you about the possible side effects of the treatments before you take part in the trial.