A study to learn more about breast cancer that has spread to the brain (PRIMROSE study)
Cancer type:
Status:
Phase:
This study wants to find out more about breast cancer that has spread to the brain (secondary brain cancer).
The PRIMROSE study includes different studies. This summary includes information about the:
- PRIMROSE Tissue study
- PRIMROSE CSF study
The team will ask you to go into only one of these studies.
More about this trial
Research shows that more people are developing breast cancer that spreads to their brain (secondary brain cancer). This is because of the improved treatments for breast cancer which means more people are living longer.
Unfortunately, the drug treatments that normally work for breast cancer don’t work very well for cancer that has spread to the brain.
At the moment there is little research about breast cancer that spreads to the brain and how to treat it.
In the PRIMROSE studies the team want to learn more about breast cancer that spreads to the brain to help improve treatments. The study team will look at the differences between changes in the cells of the 
and the cancer that has spread to other parts of the body. They are also looking for changes that might help them diagnose and treat breast cancer that has spread to the brain.
PRIMROSE Tissue study
For this study the team ask for tissue samples that have already been taken as part of standard care. These samples are from the:
- primary breast cancer
- breast cancer that has spread to the brain or other parts of the body
- fluid surrounding the brain and spinal cord (CSF). If your doctor takes one.
PRIMROSE CSF study
For this study the team ask you for a sample of the fluid surrounding the brain and spinal cord (CSF). This is not usually taken as a part of standard care. It is part of this study.
To collect the CSF sample you have a . Or the doctors can take the sample from your ommaya reservoir if you have one.
The study team also ask for a blood sample. This is so they can look for from cancer cells in your blood (circulating DNA).
The aim of the PRIMROSE studies is to look at and compare samples from the primary breast cancer and the breast cancer that has spread to the brain.
In the PRIMROSE CSF study, they also want to find out how acceptable it is for people to have the CSF samples taken.
Please note
Taking part in this study won’t change your treatment or care. The information gathered might help other people in the future who have breast cancer that has spread to the brain.
Who can enter
The following bullet points are a summary of 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 have breast cancer that has spread to the brain or to the tissue surrounding the brain (leptomeningeal metastases).
- The team can access tissue samples of your breast cancer and tissue samples of where the breast cancer has spread to.
- You are at least 16 years old.
Trial design
PRIMROSE Tissue study
The team wants to collect samples of cancer tissue from 300 women and men with breast cancer that has spread to the brain.
Where available the team ask for the following breast cancer tissue samples, from the:
- primary breast cancer
- breast cancer that has spread outside of the breast, such as liver, lung or bone
- breast cancer that has spread to the brain
They will ask for a sample of the fluid from around your brain if your doctor plans to test this fluid as part of your routine care. To collect the sample they do a procedure called a lumbar puncture.
They will also ask for a blood sample at the same time.
PRIMROSE CSF study
The team wants to recruit 67 to 87 breast cancer patients with disease in the brain or spinal cord (the central nervous system).
You have a lumbar puncture and a blood sample taken. This is not a part of your routine care.
A month after the lumbar puncture a team member will contact you. They may phone you or see you at one of your clinic appointments. They’ll ask about your experience of having the lumbar puncture done.
The team might ask you to have another lumbar puncture done. You don’t have to agree to have this second one done.
Both studies
The team will look at your medical records to find out information about any scans you have had as part of your routine care.
Hospital visits
There are no extra visits if you take part in the tissue study.
In the CSF study you have an extra hospital visit for the lumbar puncture. And another if you agree to have the 2nd lumbar puncture done.
Side effects
There are no side effects if you agree to join the study.
There are side effects from the routine procedures your doctor might do. They will talk to you about the possible side effects before you have these done.
We have information about:
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 Carlo Palmieri
Supported by
Daiichi Sankyo
University of Liverpool
North West Cancer Research
Make 2nds Count
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
