A trial to find out how useful a blood test is to monitor people with breast cancer (TRAK-ER)
Cancer type:
Status:
Phase:
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 
or a .
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 (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 and a sub study. There are different entry conditions for the surveillance part, the treatment part and the sub study.
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
Surveillance part
You may be able to join the surveillance part of the trial if all of the following 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
Treatment part
You may be able to join the treatment part if both of the following apply. You:
- have satisfactory blood test results
- are willing to have a drug called
goserelin or similar medications during treatment. This is for people who haven’t gone through the menopause.
Stereotactic radiotherapy sub study
You may be able to join the sub study if the following apply. You:
- have been diagnosed with breast cancer that has spread to another part of the body but the areas of spread are few in number and small in size. This can be during either the surveillance or treatment part.
- are able to be treated with
stereotactic body radiotherapy . Your doctor will know this. - are willing to have frequent blood tests
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
Stereotactic radiotherapy sub study
You cannot join this trial if any of these apply. You:
- have cancer that has spread to the lungs or brain
- need to start treatment straight away
- have other medical conditions such as lupus, sclerosis, lung disease and inflammatory bowel disease that could affect you taking part in the sub study
Trial design
This is a phase 2 trial.
There is a surveillance part, treatment part and the stereotactic radiotherapy (SBRT) sub study in this 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
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 .
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.
SBRT sub study
This sub study is looking at stereotactic body radiotherapy (SBRT also called SABR or SRT) to treat small areas of cancer spread in the body. The team need 49 to 56 people to take part.
The team might ask you to join the sub study if your blood samples show . And scans show that your cancer has spread and these can be treated with SBRT
During the sub study the team take regular:
- blood samples
- CT scans or whole body MRI scans
The aims of the sub study are to find out:
- how ctDNA changes in people after SBRT for breast cancer spread that is few in number and small in size
- how this treatment affects quality of life
Quality of life
During the treatment part and the SBRT sub study 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.
Samples for research
During the trial if your cancer comes back the team will ask for a tissue sample () of it.
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.
Stereotactic radiotherapy (SBRT) sub study
You see the doctor to have tests before and after treatment. These tests include:
You see the doctor:
- at 4 weeks after SBRT treatment
- every 3 months for up to 3 years
- then every 6 months in years 3 to 5
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:
- palbociclib and its side effects
- fulvestrant and its side effects
- hormone therapy for breast cancer
- radiotherapy side effects
Your doctor will talk to you about the possible side effects of the treatments and answer any questions you have before you take part in the trial.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Nick Turner
Supported by
Invitae
Institute of Cancer Research (ICR)
Pfizer
Royal Marsden Hospital Charitable Fund
The Royal Marsden NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
