New developments and clinical trials

Can a cure be found?

In most major breast units, research into finding better ways of treating breast cancer is going on all the time. As none of the current treatments results in a cure for all patients, doctors in these units are looking continually for new and better ways to treat breast cancer.

Clinical trials

One way of investigating treatments is through clinical trials that involve trying out new drugs in patients. Before a clinical trial takes place on a drug a lot of early work and tests are performed.

If the early work suggests that the new treatment might be better than the current standard treatment, doctors carry out trials to compare the new treatment with the best available standard treatment. This is called a controlled clinical trial and is the only reliable way of testing a new treatment.

Usually these trials are carried out in several hospitals around the country to get enough patients into the trial. To make sure that the results are not biased, often you and your doctor will not know whether you are taking the new drug or the standard treatment.

Taking part in a clinical trial

In randomised controlled clinical trials some patients will receive the best standard treatment and others will receive the new treatment.

In such a trial you cannot choose which treatment you receive; a computer assigns you to the standard or the new treatment. This method of randomisation ensures that equal numbers of patients get both treatments and removes bias.

Eventually, when the trial is completed it is possible to tell whether the new treatment is any better than the standard treatment.

It is important to realise that not all trials show that the new treatment is better. If you enter a trial and do not get the new treatment, you should not be too disappointed. If you do not receive the test treatment in the trial you will receive the best standard treatment, which is what you would have had if you had not entered the trial.

Before any trials are allowed to take place, the trial needs to be approved by an ethics committee. Patients also need to sign an informed consent form before entering any clinical trial. This consent means that patients know what the trial is about, understand why it is being conducted and why they have been invited to take part.

Clinical trials

Phase 1

A small number of healthy volunteers, usually between 10 and 12 people, are selected for the first set of trials. These tests work out whether the medicine is safe.

Phase 2

Trials are designed to see if a new medicine works in a small number of patients with the condition or disease being tested. Between 100 and 200 patients are selected and monitored to see if they have mild or severe side effects.

Phase 3

The largest number of patients so far is selected (perhaps between 1,000 and 3,000) to take the medicine under medical supervision for approximately six months. Phase 3 trials are usually carried out in a hospital or clinic setting and may involve a number of different countries.

If the results are satisfactory, they will be presented to the licensing and other relevant authorities who decide whether or not to give them a licence.

Phase 4

Even when newly licensed medicines are launched, they are still tested and many thousands of patients help to continue the research and help doctors. Doctors are looking to see how the new medicine is used in a real-life situation, when a patient is at home or work. If the medicine has a very rare side effect, for example a reaction that will affect one person in 50,000 taking the medicine, then it is extremely unlikely that these side effects will be discovered until after the new medicine is available to be prescribed.

Even after patients agree to take part in the trial they can withdraw at any stage if they change their mind. Importantly your decision as to whether to enter or withdraw from the trial will not affect your treatment or your doctor’s attitude towards you.

KEY POINTS

Trials of new drugs are going on all the time to try to improve the outcome of treatment for breast cancer
If you are asked to take part in such a trial your decision will not affect your treatment or your doctor’s attitude to you
If you enter a trial you can withdraw at any time without giving a reason