
“I had treatment last year and I want to give something back.”
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:
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:
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:
You may be able to join the surveillance part of the trial if all of the following also apply. You:
You may be able to join the treatment part if all of the following also apply. You:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
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 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.
Samples for research
During the trial if your cancer comes back the team will ask for a tissue sample () of it.
Quality of life
During the treatment part you fill in a questionnaire. The questions ask about:
This is a quality of life questionnaire.
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:
You see the doctor:
You have a CT scan and bone scan every 6 months.
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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Nick Turner
Invitae
Institute of Cancer Research (ICR)
Pfizer
Royal Marsden Hospital Charitable Fund
The Royal Marsden NHS Foundation Trust
Freephone 0808 800 4040
“I had treatment last year and I want to give something back.”