Clinical trials

Clinical trials are research studies that aim to improve diagnosis, treatment, side effects and quality of life.

For people with breast cancer, clinical trials might include:

• Looking at ways to reduce the risk of getting breast cancer
• Improving ways to diagnose breast cancer
• Testing new cancer drugs to find out more about them and any side effects
• Testing new treatments to see if they work better than current treatments
• Testing whether existing drugs used for other conditions can treat breast cancer
• Testing current treatments in different ways to reduce side effects
• Finding new ways to combine treatments to see if they work better
• Testing whether aspects of breast cancer treatment (such as chemotherapy, radiotherapy, targeted therapies or surgery) can be reduced or safely avoided altogether
• Looking at the effect a treatment has on everyday life (quality of life)
• Looking at whether psychological support makes a difference to your experience of cancer or its treatment

Whether you can take part in a clinical trial will depend on different factors, like the type of breast cancer you have, its features and your general health.

Find out more about clinical trials for breast cancer and the types of clinical trial you may be offered on the Cancer Research UK website. There’s also more information towards the end of this webpage.

If you’re interested in taking part

If you’re interested in taking part in a clinical trial, talk it through with your treatment team. They will be aware of suitable breast cancer trials for you. They can refer you to the research team, which will include a research nurse, who can give you more information about the trial and other factors to consider, such as transport or costs.

Every clinical trial has strict guidelines about who can be involved. The guidelines are called the eligibility criteria and may include:

• The stage of cancer
• The size of cancer
• The type of breast cancer you have
• Previous treatment you’ve had
• Other health problems you have

Some trials may need you to take part at a certain point in your treatment, for example within a year of having surgery. Your research team will make you aware if this is the case.

If you’ve been asked to take part

Your treatment team may ask if you want to take part in a clinical trial.

If you’ve been asked to take part in a trial, your treatment team or a research nurse will discuss exactly what’s involved with you. They should give you written information with all the details of the trial. This is usually called a participant information sheet (PIS). This will include information about the type of trial, the possible benefits and risks, and whether you’ll need extra tests or hospital appointments.

It’s important you understand what is involved before you agree to take part, so you should be given time to make a decision about whether taking part in the trial is right for you.

Deciding to take part

Deciding whether to take part in a clinical trial can be difficult and you might feel anxious about making a choice. You may want to talk to friends or family about your decision. Whatever you decide, your treatment team will continue to support you and offer you the best treatment and care available. They can also talk you through your choice, answer any questions you have and address any worries.

If you do not feel taking part in a trial is the right option for you, you can say no without giving a reason. This will not affect your care. It’s important to remember clinical trials are optional. You only need to take part if you want to.

You might feel disappointed if you’re not eligible to take part in a clinical trial you were interested in. You can talk to your research team about why you were not eligible and they might be able to suggest other trials you could take part in.

Questions to ask

It’s important to ask any questions you have about the clinical trial. You might want to write them down and have a list with you when you speak to the research nurse or your treatment team.

Here’s a list of questions that might be helpful:

• What’s the purpose of the trial?
• How many people are in the trial?
• How long will I take part in the trial for?
• What will I be asked to do during the trial?
• Can I have this treatment outside of the trial?
• What are the benefits and risks of taking part in the trial?
• Will I have to go to a different clinic or hospital?
• Will I still be under the care of my current treatment team?
• How will you use any data collected about me?
• Will I need to donate blood or tissue? Is this optional?
• What extra tests will I need to have?
• What side effects might I have?
• What treatment will I have if I decide not to take part in the trial?
• Who should I contact if I have any concerns during the trial?
• Will I be reimbursed for my travel expenses?
• Who do I talk to if I want to leave the trial?

Giving consent

If you decide to take part in a clinical trial and fit the eligibility criteria, you’ll be asked to sign a form saying you agree to take part and understand what is involved. This is called giving informed consent. You can still withdraw from the trial at any time if you change your mind.

You do not need to give the research team a reason for leaving the trial. But if you do want to let them know, it can be helpful for their future work to understand why you decided to leave. Leaving the trial will not affect any future care you receive.

You cannot be entered into a clinical trial without your knowledge and without giving your written consent.

Benefits of taking part in a clinical trial might include:

• Being one of the first people to benefit from a new treatment
• Having the opportunity to help others and improve breast cancer treatment
• Having extra appointments and tests, which may mean you feel more supported and closely monitored

Drawbacks of taking part in a clinical trial might include:

• Unexpected side effects from a new treatment or an existing treatment given in a different way
• The new treatment not being any more effective than the standard treatment
• The new treatment being effective for some, but not for you
• Additional appointments that take up time
• Additional appointments that may make you feel anxious
• Depending on the type of trial, not receiving the new, or additional, treatment

You can find out more about clinical trials on the NHS website. And you can search Cancer Research UK's online database or the Be Part of Research website for details of clinical trials that you can take part in.

You can find more information on research projects and clinical trial opportunities on our forum.

People living with metastatic (secondary) breast cancer can find clinical trials through Make 2nds Count's Clinical Trials Service. The service matches people living with metastatic breast cancer to a nurse who can talk you through the process and help you find clinical trials to take part in. 

You could also ask a member of your treatment team if they know about any clinical trials you might be eligible for.

You can speak to others who are thinking about or taking part in clinical trials on our forum.

If you have primary breast cancer, our Someone Like Me service can put you in touch with someone who has had a similar experience. You can talk through your worries and share experiences over the phone or by email. See the bottom of this page for ways to get in touch.

You can listen to other people’s experiences of clinical trials on the Healthtalk website.

If you want further information and support about clinical trials for breast cancer or just want to talk things through, you can speak to one of our nurses by calling our free helpline. See the bottom of this page for how to get in touch.