This study is looking at all the genetic information (genome) of people with breast cancer to help improve treatment
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Status:
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This study is looking at all the genetic information (genome) of people with breast cancer to help improve treatment. It is called the Personalised Breast Cancer Programme (PBCP).
Cancer Research UK supports this study.
More about this trial
Your genome is all the
Your cancer also has its own genome.
It is now possible to look at the whole of your genome and your cancer genome. To do this, researchers analyse tissue samples (
- understand and identify the changes in DNA that might make you more likely to develop diseases such as breast cancer
- better compare your healthy cells to your cancer cells to find out why cancer grows and spreads
- help them treat cancer better
- see exactly where the changes in the genome happen that cause cancer
- better identify the different types of breast cancer
- work out if you are more likely to get side effects from treatment
- find information that might be important to other members of your family
In this study the team look at the genome of people with breast cancer. They hope this will help doctors decide the best treatment for everyone based on the genetic makeup of their cancer.
The main aims of this study are to find out whether it is possible:
- to look at the genome and the cancer genome of people with breast cancer and
- to use the results to tailor their treatment
Please note there is not enough information about the changes in the genome to affect the
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 invasive breast cancer
- are up and about, can look after yourself but might not be able to work (performance status 0, 1 or 2)
- are having surgery to remove your cancer or you are having a sample of tissue (
biopsy ) taken from your cancer. You might be able to join if you have already had surgery or a biopsy if the fresh tissue is available for research. - are at least 16 years old
Who can’t take part
You cannot join this study if your doctor or a member of the study team think any of the following might affect you taking part:
- you have a mental health condition
- your family situation, for example it might cause too much stress
- where you live, for example you live too far away from any of the participating hospitals
Trial design
The study team need 2,000 people to take part in the study.
You have blood and tissue samples taken by the team. They will explain when you have these. It depends on what treatment you have.
They use these samples to look at the genes that are associated with breast cancer. This is whole genome sequencing. They are looking for changes in the genes that:
- come from your parents (
inherited gene changes) - happen due to cancer (these are changes that aren’t inherited)
The team are only looking for known gene changes. If they find an inherited gene change such as
Your doctor might receive some results if they are relevant to your breast cancer and its treatment. They can share this with you.
You fill in a questionnaire. The questions ask about your:
- medical history
- social history, such as smoking and drinking alcohol
- family cancer history and genetic testing
The team will look at your medical record and notes for a period of 10 years.
The team might ask for fresh samples of tissues during your treatment or if you have a new cancer diagnosed. You don’t have to agree to these. You can still take part in the study.
Microbiome sub study
- your health
- how well cancer treatment works for you
- how bad the side effects of treatment might be for you
In this sub study, researchers want to look at the microbiome in the gut. They do this by looking at a sample of poo (faeces). When you provide these samples depends on whether you have:
- surgery as your first treatment, or
- other treatment, such as chemotherapy, before your surgery
If you have surgery first, you give a sample of poo:
- before your surgery
- 3 to 6 months after your surgery
If you are having other treatment and not having surgery, or before having surgery, you give a sample:
- before starting your treatment
- halfway through your treatment
- before your surgery
- 3 to 6 months after your surgery
The team give you the sample kits or post them to you. Instructions on how to take the samples are in the kit. You take the sample 2 to 3 days before your hospital appointment. You then take the sample with you when you go to appointment.
You don’t have to agree to take part in this sub study.
Blood sample sub study
The team ask you to give extra blood samples. This sub study is looking for
If you have surgery, you have blood samples taken:
- before surgery
- straight after surgery if possible while you are still in the operating theatre
- a few weeks after when you go to the hospital for your routine check up after surgery
- 3 months after surgery
- 6 months after surgery
- 12 months after surgery
- 18 months after surgery
- then every year for 5 years
They will also ask for a blood sample if your cancer comes back or you have another cancer diagnosed.
If you have other treatment and not having surgery , or before having surgery, you have blood samples taken:
- before starting treatment
- before your 2nd treatment
- halfway through treatment
- when you finish treatment before your surgery
- straight after surgery if possible while you are still in the operating theatre
- a few weeks after when you go to the hospital for your routine check up after surgery
- 3 months after surgery
- 6 months after surgery
- 12 months after surgery
- 18 months after surgery
- then every year for 5 years
They will also ask for a blood sample if your cancer comes back or you have another cancer diagnosed.
You don’t have to agree to take part in this sub study.
Hospital visits
The team have tried to arrange these samples when you have your routine appointments. There shouldn’t be any, or very few, extra hospital visits
Side effects
Having a blood sample or tissue sample can cause some discomfort, bleeding and bruising.
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
Dr Jean Abraham
Supported by
Cambridge University Hospitals NHS Foundation Trust
Cancer Research UK
Mark Foundation
University of Cambridge
Addenbrookes Charitable Trust
Oncobiome
Experimental Cancer Medicine Centres (ECMC)
National Institute for Health Research (NIHR)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040