Many patients with advanced breast cancer will be asked if they would consider taking part in a clinical trial. Before deciding whether to take part patients should understand how clinical trials work and the benefits it may have.

Clinical trial phases for breast cancer

Phase I – Safety, benefits and action
Assesses new treatments for safety and tolerability

Phase II – Dosage and Efficacy
Refining the treatment protocol, determining the right dose and measuring how effective the drug is

Phase III – Comparison to standard of care
Comparing a new drug against what is currently being used to treat a particular type of cancer. This is the most common type of clinical trial for breast cancer. Most patients who take part in clinical trials will be in a phase III trial.

Different clinical trials will look at different components of the disease. Professor of Medical Oncology, Rob Coleman explains the different outcomes a clinical trial in breast cancer may be looking for: “For the patient, what she wants is a remission of the disease, relief from the symptoms and to extend her life. For drug development, the focus is on hard endpoints that clearly show that the new drug is making a difference. The most robust endpoint is overall survival. If you can develop a drug and show that it improves how long people live for then nobody can argue with that.

However it is more common a research team would be looking at what are called surrogates for outcomes. The most commonly used surrogate is what we call progression free survival; this is the time between starting a treatment and the cancer subsequently getting worse. Improving progression free survival will generally be an advantage to the patient.  Yet for some drugs it is not about survival but about trying to improve quality of life or symptoms. An example is drugs that are used to prevent bone complications from cancer. These drugs won’t extend survival or even progression free survival but they will reduce pain, fractures and the complications of cancer going to the bone.  In effect they are improving the quality of life of that patient.”

There are advantages and disadvantages to taking part in a clinical trial and every patient has to decide whether the benefits outweigh the risks for them.

Some of the benefits in taking part in a clinical trial include:

•    A treatment that may work a little better
•    More attention and closer monitoring of the patient’s disease
•    Additional support

Professor Rob Coleman reassures patient’s that there is nothing to be frightened of in taking part in a clinical trial. The research team will always explain what is going on. If at any point a patient changes their mind, they are free to withdraw from the trial.

“There is little to be lost by signing up to a clinical trial - and a lot to gain.” Professor of Medical Oncology, Rob Coleman

To participate in a clinical trial or to find out more ask your doctor or go to www.cancerhelp.org.uk

Professor Rob Coleman, MBBS, MD, FRCP (London & Edinburgh)
Honorary Consultant, Weston Park Hospital
Professor of Medical Oncology, Weston Park Hospital, Sheffiled

10014 October 2011